101 Examples 1to36
101 Examples 1to36
The following examples should be used in conjunction with the 2014 Interim Eligibility
Guidance. As the examples are intended to be illustrative only, they should be interpreted based
on the fact patterns set forth below. Other fact patterns may have different eligibility outcomes.
This set of examples is arranged into two parts. The first part includes four fact patterns with
claims that are patent eligible, several of which draw from U.S. Court of Appeals for the Federal
Circuit decisions, and the second part includes four fact patterns with claims that were found
ineligible by the Federal Circuit. Each of the examples shows how claims should be analyzed
under the 2014 Interim Eligibility Guidance. All of the claims are analyzed for eligibility in
accordance with their broadest reasonable interpretation.
Part One
These examples show claims that would be patent eligible when analyzed under the 2014 Interim
Eligibility Guidance. The first example is a hypothetical claim and fact pattern that illustrates an
eligible software invention that is not directed to an abstract idea. The second example is a
recent Federal Circuit decision. The third and fourth examples are informed by Federal Circuit
decisions where claims were found eligible, but are drafted as hypothetical claims modified to
prominently add an abstract idea for teaching purposes to facilitate analysis under the
“significantly more” prong of the 2014 Interim Eligibility Guidance.
1
Examples: Abstract Ideas
3. continue scanning until no further beginning malicious code marker is found; and
4. create a new data file by sequentially copying all non-flagged data bytes into the new
file, which thus forms a sanitized communication file.
The new, sanitized communication is transferred to a non-quarantine sector of the computer
memory. Subsequently, all data on the quarantine sector is erased.
Claims
1. A computer-implemented method for protecting a computer from an electronic
communication containing malicious code, comprising executing on a processor the steps of:
receiving an electronic communication containing malicious code in a computer with a
memory having a boot sector, a quarantine sector and a non-quarantine sector;
storing the communication in the quarantine sector of the memory of the computer,
wherein the quarantine sector is isolated from the boot and the non-quarantine sector in the
computer memory, where code in the quarantine sector is prevented from performing write
actions on other memory sectors;
extracting, via file parsing, the malicious code from the electronic communication to
create a sanitized electronic communication, wherein the extracting comprises
scanning the communication for an identified beginning malicious code marker,
flagging each scanned byte between the beginning marker and a successive end
malicious code marker,
continuing scanning until no further beginning malicious code marker is found,
and
creating a new data file by sequentially copying all non-flagged data bytes into a
new file that forms a sanitized communication file;
transferring the sanitized electronic communication to the non-quarantine sector of the
memory; and
deleting all data remaining in the quarantine sector.
2
Examples: Abstract Ideas
extracting, via file parsing, the malicious code from the electronic communication to
create a sanitized electronic communication, wherein the extracting comprises
scanning the communication for an identified beginning malicious code marker,
flagging each scanned byte between the beginning marker and a successive end
malicious code marker,
continuing scanning until no further beginning malicious code marker is found,
and
creating a new data file by sequentially copying all non-flagged data bytes into a
new file that forms a sanitized communication file;
transferring the sanitized electronic communication to the non-quarantine sector of the
memory; and
deleting all data remaining in the quarantine sector.
Analysis
Claim 1: Eligible.
The method claim recites a series of acts for protecting a computer from an electronic
communication containing malicious code. Thus, the claim is directed to a process, which is one
of the statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The
claimed invention relates to software technology for isolation and extraction of malicious code
contained in an electronic communication. The claim is directed towards physically isolating a
received communication on a memory sector and extracting malicious code from that
communication to create a sanitized communication in a new data file. Such action does not
describe an abstract concept, or a concept similar to those found by the courts to be abstract, such
as a fundamental economic practice, a method of organizing human activity, an idea itself
(standing alone), or a mathematical relationship. In contrast, the invention claimed here is
directed towards performing isolation and eradication of computer viruses, worms, and other
malicious code, a concept inextricably tied to computer technology and distinct from the types of
concepts found by the courts to be abstract. Accordingly, the claimed steps do not recite an
abstract idea. Nor do they implicate any other judicial exception. Accordingly, the claim is not
directed to any judicial exception (Step 2A: NO). The claim is eligible.
Claim 2: Eligible.
The claim is directed to a non-transitory computer-readable medium, which is a manufacture,
and thus a statutory category of invention (Step 1: YES).
The claim recites the same steps as claim 1 stored on a non-transitory computer readable medium
such that they are executable on a processor. The invention described by those steps is not
directed towards an abstract idea, for the reasons explained above (Step 2A: NO). The claim is
eligible.
3
Examples: Abstract Ideas
4
Examples: Abstract Ideas
Representative Claim
19. A system useful in an outsource provider serving web pages offering
commercial opportunities, the system comprising:
(a) a computer store containing data, for each of a plurality of first web pages,
defining a plurality of visually perceptible elements, which visually perceptible
elements correspond to the plurality of first web pages;
(i) wherein each of the first web pages belongs to one of a plurality of web
page owners;
(ii) wherein each of the first web pages displays at least one active link
associated with a commerce object associated with a buying opportunity
of a selected one of a plurality of merchants; and
(iii) wherein the selected merchant, the outsource provider, and the owner
of the first web page displaying the associated link are each third parties
with respect to one other;
(b) a computer server at the outsource provider, which computer server is coupled
to the computer store and programmed to:
(i) receive from the web browser of a computer user a signal indicating
activation of one of the links displayed by one of the first web pages;
(ii) automatically identify as the source page the one of the first web pages
on which the link has been activated;
(iii) in response to identification of the source page, automatically retrieve
the stored data corresponding to the source page; and
(iv) using the data retrieved, automatically generate and transmit to the
web browser a second web page that displays: (A) information associated
with the commerce object associated with the link that has been activated,
and (B) the plurality of visually perceptible elements visually
corresponding to the source page.
Analysis
Claim 19: Eligible.
The claim recites a system comprising a computer server and computer store. The system
comprises a device or set of devices and, therefore, is directed to a machine which is a statutory
category of invention (Step 1: YES).
Next, the claim is analyzed to determine whether it is directed to a judicial exception. This claim
recites a system “useful in outsource provider serving web pages offering commercial
opportunities,” but is directed to automatically generating and transmitting a web page in
response to activation of a link using data identified with a source web page having certain
visually perceptible elements. The claim does not recite a mathematical algorithm; nor does it
recite a fundamental economic or longstanding commercial practice. The claim addresses a
business challenge (retaining website visitors) that is particular to the Internet. The claimed
5
Examples: Abstract Ideas
invention differs from other claims found by the courts to recite abstract ideas in that it does not
“merely recite the performance of some business practice known from the pre-Internet world
along with the requirement to perform it on the Internet. Instead, the claimed solution is
necessarily rooted in computer technology in order to overcome a problem specifically arising in
the realm of computer networks.” No idea similar to those previously found by the courts to be
abstract has been identified in the claim. During examination, if the examiner does not identify
an abstract idea recited in the claim, the claim should be deemed to be not directed to a judicial
exception (Step 2A: NO). The claim is eligible.
Under the 2014 Interim Eligibility Guidance no further analysis would be necessary. In this
decision, however, the court went on to point out certain features of the claim that amount to an
inventive concept for resolving this particular Internet-centric problem, rendering the claims
patent eligible. An excerpt of the court’s discussion follows:
In particular, the ′399 patent's claims address the problem of retaining website visitors
that, if adhering to the routine, conventional functioning of Internet hyperlink protocol,
would be instantly transported away from a host's website after “clicking” on an
advertisement and activating a hyperlink. For example, asserted claim 19 recites a system
that, among other things, 1) stores “visually perceptible elements” corresponding to
numerous host websites in a database, with each of the host websites displaying at least
one link associated with a product or service of a third-party merchant, 2) on activation of
this link by a website visitor, automatically identifies the host, and 3) instructs an Internet
web server of an “out-source provider” to construct and serve to the visitor a new, hybrid
web page that merges content associated with the products of the third-party merchant
with the stored “visually perceptible elements” from the identified host website. [ ]
In more plain language, upon the click of an advertisement for a third-party product
displayed on a host's website, the visitor is no longer transported to the third party's
website. Instead, the patent claims call for an “outsource provider” having a web server
which directs the visitor to an automatically-generated hybrid web page that combines
visual “look and feel” elements from the host website and product information from the
third-party merchant's website related to the clicked advertisement. [ ] In this way,
rather than instantly losing visitors to the third-party's website, the host website can
instead send its visitors to a web page on the outsource provider's server that 1)
incorporates “look and feel” elements from the host website, and 2) provides visitors with
the opportunity to purchase products from the third-party merchant without actually
entering that merchant's website.
As the court cautioned, “not all claims purporting to address Internet-centric challenges are
eligible,” but in this case these additional limitations amount to more than simply stating “apply
the abstract idea on the Internet.” Therefore, when taken as a whole, the claimed invention has
additional limitations that amount to significantly more than the abstract idea. Under this
reasoning, the claim recites patent eligible subject matter (Step 2B: YES).
6
Examples: Abstract Ideas
7
Examples: Abstract Ideas
Analysis
Claim 1: Eligible.
The method claim recites a series of acts for generating a blue noise mask and using that blue
noise mask to halftone a gray scale image. Thus, the claim is directed to a process, which is one
of the statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The
claim recites the step of generating a blue noise mask, which as defined in the background is
produced through an iterative mathematical operation. The courts have found that mathematical
relationships fall within the judicial exceptions, often labelled as “abstract ideas.” Since the
mathematical operation of generating a blue noise mask is recited in the claim, the claim is
“directed to” a judicial exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine if there are additional limitations recited in
the claim such that the claim amounts to significantly more than the mathematical operation.
There are several additional limitations recited in the claim besides the mathematical operation
of generating a blue noise mask. First, the claim recites using a processor to generate the blue
8
Examples: Abstract Ideas
noise mask. The claim also recites the steps of storing the blue noise mask in a first memory
location and receiving a gray scale image and storing the gray scale image in a second memory
location. Thus, the claim uses a processor and memory to perform these steps of calculating a
mathematical operation and receiving and storing data. The addition of general purpose
computer components alone to perform such steps is not sufficient to transform a judicial
exception into a patentable invention. The computer components are recited at a high level of
generality and perform the basic functions of a computer (in this case, performing a
mathematical operation and receiving and storing data) that would be needed to apply the
abstract idea via computer. Merely using generic computer components to perform the above
identified basic computer functions to practice or apply the judicial exception does not constitute
a meaningful limitation that would amount to significantly more than the judicial exception, even
though such operations could be performed faster than without a computer.
The claim also recites the additional steps of comparing the blue noise mask to a gray scale
image to transform the gray scale image to a binary image array and converting the binary image
array into a halftoned image. These additional steps tie the mathematical operation (the blue
noise mask) to the processor’s ability to process digital images. These steps add meaningful
limitations to the abstract idea of generating the blue noise mask and therefore add significantly
more to the abstract idea than mere computer implementation. The claim, when taken as a
whole, does not simply describe the generation of a blue noise mask via a mathematical
operation and receiving and storing data, but combines the steps of generating a blue noise mask
with the steps for comparing the image to the blue noise mask and converting the resulting
binary image array to a halftoned image. By this, the claim goes beyond the mere concept of
simply retrieving and combining data using a computer.
Finally, viewing the claim elements as an ordered combination, the steps recited in addition to
the blue noise mask improve the functioning of the claimed computer itself. In particular, as
discussed above, the claimed process with the improved blue noise mask allows the computer to
use to less memory than required for prior masks, results in faster computation time without
sacrificing the quality of the resulting image as occurred in prior processes, and produces an
improved digital image. These are also improvements in the technology of digital image
processing. Unlike the invention in Alice Corp., the instant claim is not merely limiting the
abstract idea to a computer environment by simply performing the idea via a computer (i.e., not
merely performing routine data receipt and storage or mathematical operations on a computer),
but rather is an innovation in computer technology, namely digital image processing, which in
this case reflects both an improvement in the functioning of the computer and an improvement in
another technology. Taking all the additional claim elements individually, and in combination,
the claim as a whole amounts to significantly more than the abstract idea of generating a blue
noise mask (Step 2B: YES). The claim recites patent eligible subject matter.
Claim 2: Eligible.
The claim recites a non-transitory computer-readable medium with stored instructions. The term
“non-transitory” ensures the claim does not encompass signals and other transitory forms of
signal transmission. Therefore, the claim is directed to a manufacture (an article produced from
materials), which is a statutory category of invention (Step 1: YES).
The claim recites the same steps as claim 1. Therefore, the claim is directed to the same abstract
idea identified in claim 1 which is the mathematical operation of generating a blue noise mask
9
Examples: Abstract Ideas
(Step 2A: YES). Similarly, the claim recites the same additional elements of comparing the blue
noise mask to a gray scale image to transform the gray scale image to a binary image array and
converting the binary image array into a halftoned image. These additional elements add
significantly more to the abstract idea as evidenced by the improved functioning of the computer
in halftoning a gray scale image and the improved digital image processing. For the same
reasons set forth above, taking all the additional claim elements individually, and in combination,
the claim as a whole amounts to significantly more than the abstract idea of generating a blue
noise mask (Step 2B: YES). The claim recites patent eligible subject matter.
Claim 3: Eligible.
The claim recites a system comprising a processor, a first memory and a second memory. The
claim is directed to statutory category of invention, i.e. a machine (a combination of devices)
(Step 1: YES).
The claim recites the same abstract idea as identified with regard to claim 1, which is the
mathematical operation of generating a blue noise mask, and thus is directed to the abstract idea
(Step 2A: YES). Similarly, the claim recites the same additional elements that compare the blue
noise mask to a gray scale image to transform the gray scale image to a binary image array and
convert the binary image array into a halftoned image that add significantly more to the abstract
idea. For the same reasons set forth above, taking all the additional claim elements individually,
and in combination, the claim as a whole amounts to significantly more than the abstract idea of
generating a blue noise mask (Step 2B: YES). The claim recites patent eligible subject matter.
10
Examples: Abstract Ideas
Claims
1. A system for calculating an absolute position of a GPS receiver and an absolute time of
reception of satellite signals comprising:
a mobile device comprising a GPS receiver, a display, a microprocessor and a wireless
communication transceiver coupled to the GPS receiver, the mobile device programmed to
receive PN codes sent by a plurality of GPS satellites, calculate pseudo-ranges to the plurality of
GPS satellites by averaging the received PN codes, and transmit the pseudo-ranges, and
a server comprising a central processing unit, a memory, a clock, and a server
communication transceiver that receives pseudo-ranges from the wireless communication
transceiver of the mobile device, the memory having location data stored therein for a plurality
of wireless towers, and the central processing unit programmed to:
estimate a position of the GPS receiver based on location data for a wireless tower
from the memory and time data from the clock,
calculate absolute time that the signals were sent from the GPS satellites using the
pseudo-ranges from the mobile device and the position estimate,
create a mathematical model to calculate absolute position of the GPS receiver based
on the pseudo-ranges and calculated absolute time,
calculate the absolute position of the GPS receiver using the mathematical model, and
transmit the absolute position of the GPS receiver to the mobile device, via the server
communication transceiver, for visual representation on the display.
2. A method for calculating an absolute position of a GPS receiver and an absolute time of
reception of satellite signals comprising:
calculating pseudo-ranges, at a mobile device comprising a GPS receiver, a microprocessor,
a display, and a wireless communication transceiver, by averaging PN codes received by the
GPS receiver from a plurality of GPS satellites;
11
Examples: Abstract Ideas
wirelessly transmitting the calculated pseudo-ranges from the mobile device to a server,
wherein the server comprises a central processing unit (CPU);
calculating, by the server CPU, absolute time that the PN codes were sent from the GPS
satellites to the GPS receiver using the pseudo-ranges and an estimated position of the GPS
receiver;
using a mathematical model to calculate, by the server CPU, absolute position of the GPS
receiver based on the pseudo-ranges and calculated absolute time;
transmitting the absolute position from the server to the mobile device; and
displaying a visual representation of the absolute position on the display of the mobile
device.
Analysis
Claim 1: Eligible.
The claim is directed to a statutory category, because a system including a mobile device and a
server satisfies the requirements of a machine (as a combination of devices) (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The
claim recites mathematical operations (e.g., calculating pseudo-ranges and absolute times, and
the mathematical model), which the courts have considered to fall within the judicial exceptions,
e.g., as abstract ideas. Because these mathematical operations are recited in the claim, the claim
is directed to a judicial exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine whether any element, or combination of
elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
First, the claim recites using a central processing unit (CPU) for performing the mathematical
operations of estimating position, calculating absolute time, and calculating absolute position
using a mathematical model. The claim also recites using location data stored in a memory, and
time data from a clock. These computer components are recited at a high level of generality and
add no more to the claimed invention than the components that perform basic mathematical
calculation functions routinely provided by a general purpose computer. Limiting performance
of the mathematical calculations to a general purpose CPU, absent more, is not sufficient to
transform the recited judicial exception into a patent-eligible invention.
However, the claim is further limited to a mobile device comprising a GPS receiver,
microprocessor, wireless communication transceiver and a display that receives satellite data,
calculates pseudo-ranges, wirelessly transmits the calculated pseudo-ranges to the server,
receives location data from the server, and displays a visual representation of the received
calculated absolute position from the server. The programmed CPU acts in concert with the
recited features of the mobile device to enable the mobile device to determine and display its
absolute position through interaction with a remote server and multiple remote satellites. The
meaningful limitations placed upon the application of the claimed mathematical operations show
that the claim is not directed to performing mathematical operations on a computer alone.
Rather, the combination of elements impose meaningful limits in that the mathematical
operations are applied to improve an existing technology (global positioning) by improving the
signal-acquisition sensitivity of the receiver to extend the usefulness of the technology into
12
Examples: Abstract Ideas
weak-signal environments and providing the location information for display on the mobile
device. All of these features, especially when viewed in combination, amount to significantly
more than the judicial exception (Step 2B: YES). The claim is eligible.
Claim 2: Eligible.
The claim is directed to a statutory category, because a series of steps including calculating
pseudo-ranges and wirelessly transmitting those pseudo-ranges satisfies the requirements of a
process (a series of acts) (Step 1: YES).
The claim recites the same abstract ideas identified with regard to claim 1, which are the
mathematical operations of, e.g., calculating pseudo-ranges and absolute times, and the
mathematical model. Thus, this claim is also directed to a judicial exception (Step 2A: YES).
Similarly, the claim recites the same additional elements of a server CPU estimating position,
calculating absolute time, and calculating absolute position using a mathematical model, and a
mobile device comprising a GPS receiver, microprocessor, wireless communication transceiver
and a display receiving satellite data, calculating pseudo-ranges, wirelessly transmitting the
calculated pseudo-ranges to the server, receiving a calculated absolute position from the server,
and then displaying a visual representation of the received position. For the same reasons set
forth above, taking all the additional claim elements individually, and in combination, the claim
as a whole amounts to significantly more than the mathematical operations by themselves (Step
2B: YES). The claim is eligible.
Part Two
These examples show claims that were held ineligible by the Federal Circuit. The analysis
sections are informed by the court decisions but offer exemplary hypothetical analyses under the
2014 Interim Eligibility Guidance.
13
Exampless: Abstractt Ideas
In this in
nvention, as seen in Fig. 1 reproduced d below, a d evice profilee is created based on
informatiion from a soource devicee 2, such as a digital cam mera, and froom a destinattion device 6,
such as a printer. Thhe device proofile is used to produce t he processedd image signnal 18 from the
input imaage signal 166. Spatial ch
haracteristic informationn 12, 20 and color characcteristic
informatiion 14, 22 arre provided from each deevice to an i mage processsor 4, alongg with the innput
image sig gnal 16. Thiis characteristic informaation is used to generate first data rellating to coloor
informatiion content of the imagee and second d data relatinng to spatial information content of thhe
image ussing known mathematicaal techniquess, such as Foourier analyssis to yield a Wiener Noiise
Power Sp pectrum (maathematical processing teechniques). The generatted data is inncorporated into
the devicce profile.
Represen
ntative Claim
m
10. A method of gennerating a deevice profile that describbes properties of a devicee in a digitall
image rep
production system for caapturing, transforming o r rendering an image, saaid method
comprisin
ng:
generating firrst data for describing a device depenndent transfo
formation of color
informatiion content of the imagee to a device independennt color spacee through usse of measured
chromatic stimuli andd device resp ponse characcteristic funcctions;
generating second data foor describing
g a device deependent trannsformation of spatial
informatiion content of the imagee in said deviice independdent color sppace throughh use of spatiial
stimuli an
nd device reesponse characteristic fun
nctions; andd
co
ombining saaid first and second data into the devvice profile.
Analysis
Claim 10
0: Ineligible.
The claimm is directed
d to a statutorry category, because a series of stepps for generaating data
satisfies the requirem
ments of a proocess (a seriies of acts) (SStep 1: YESS).
Next, thee claim is anaalyzed to determine wheether it is dirrected to a juudicial excepption. The claim
recites a method of generating firrst data and second data using matheematical techhniques and
combinin ng the first and second data into a deevice profile.. In other words, the claaimed methood
simply deescribes the concept of gathering and combiningg data by recciting steps of organizingg
informatiion through mathematicaal relationsh hips. The gatthering and combining merely emplloys
mathemaatical relation nships to maanipulate exiisting informmation to gennerate additioonal informaation
in the forrm of a ‘deviice profile,’ without limiit to any usee of the devicce profile. This idea is
14
Examples: Abstract Ideas
similar to the basic concept of manipulating information using mathematical relationships (e.g.,
converting numerical representation in Benson), which has been found by the courts to be an
abstract idea. Therefore, the claim is directed to an abstract idea (Step 2A: YES).
The claim does not include additional elements beyond the abstract idea of gathering and
combining data. Therefore, the claim does not amount to more than the abstract idea itself (Step
2B: NO). The claim is not patent eligible.
15
Examples: Abstract Ideas
numbers selected for play in the selected game of Bingo is less than a total number of sets of
Bingo numbers in the group;
(vi) addition by the computer of a control number for each set of Bingo numbers
selected for play in the selected game of Bingo;
(vii) output of a receipt with the control number, the set of Bingo numbers which is
preselected and selected by the player, a price for the set of Bingo numbers which is preselected,
a date of the game of Bingo and optionally a computer identification number; and
(viii) output for verification of a winning set of Bingo numbers by means of the
control number which is input into the computer by a manager of the game of Bingo.
Analysis
Claim 1: Ineligible.
Claim 1 is directed to a system comprising a computer, an input and output terminal, and a
program enabling management of the game of Bingo. The claimed system is therefore directed
to a statutory category, i.e., a machine (a combination of devices) (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exceptions. The
claim recites program elements (i) through (viii) that describe the steps of managing a game of
Bingo, including for example inputting and storing two sets of Bingo numbers, assigning a
unique player identifier and control number, and verifying a winning set of Bingo numbers.
Managing the game of Bingo as recited in the claim can be performed mentally or in a computer
and is similar to the kind of ‘organizing human activity’ at issue in Alice Corp. Although the
claims are not drawn to the same subject matter, the abstract idea of managing a game of Bingo
is similar to the abstract ideas of managing risk (hedging) during consumer transactions (Bilski)
and mitigating settlement risk in financial transactions (Alice Corp.) Claim 1 describes
managing the game of Bingo and therefore is directed to an abstract idea (Step 2A: YES).
Next, the claim is analyzed to determine whether there are additional limitations recited that
amount to significantly more than the abstract idea. The claim requires the additional limitations
of a computer with a central processing unit (CPU), memory, a printer, an input and output
terminal, and a program. These generic computer components are claimed to perform their basic
functions of storing, retrieving and processing data through the program that enables the
management of the game of Bingo. The recitation of the computer limitations amounts to mere
instructions to implement the abstract idea on a computer. Taking the additional elements
individually and in combination, the computer components at each step of the management
process perform purely generic computer functions. As such, there is no inventive concept
sufficient to transform the claimed subject matter into a patent-eligible application. The claim
does not amount to significantly more than the abstract idea itself (Step 2B: NO). Accordingly,
the claim is not patent eligible.
16
Examples: Abstract Ideas
Analysis
Claim 1: Ineligible.
The claim is directed to a process, i.e., a series of steps or acts, for providing a performance
guaranty. A process is one of the statutory categories of invention (Step 1: YES).
Next, the claim is analyzed to determine whether it is directed to a judicial exception. The claim
recites the steps of creating a contract, including receiving a request for a performance guaranty
(contract), processing the request by underwriting to provide a performance guaranty and
offering the performance guaranty. This describes the creation of a contractual relationship,
which is a commercial arrangement involving contractual relations similar to the fundamental
economic practices found by the courts to be abstract ideas (e.g., hedging in Bilski). It is also
noted that narrowing the commercial transactions to particular types of relationships or particular
17
Examples: Abstract Ideas
parts of that commercial transaction (e.g., underwriting) would not render the concept less
abstract. Thus, the claim is directed to an abstract idea (Step 2A: YES).
Analyzing the claim as whole for an inventive concept, the claim limitations in addition to the
abstract idea include a computer application running on a computer and the computer network.
This is simply a generic recitation of a computer and a computer network performing their basic
functions. The claim amounts to no more than stating create a contract on a computer and send it
over a network. These generic computing elements alone do not amount to significantly more
than the judicial exception (Step 2B: NO). The claim is not patent eligible.
1. A method for distribution of products over the Internet via a facilitator, said method
comprising the steps of:
a first step of receiving, from a content provider, media products that are covered by
intellectual property rights protection and are available for purchase, wherein each said media
product being comprised of at least one of text data, music data, and video data;
a second step of selecting a sponsor message to be associated with the media product,
said sponsor message being selected from a plurality of sponsor messages, said second step
including accessing an activity log to verify that the total number of times which the sponsor
message has been previously presented is less than the number of transaction cycles contracted
by the sponsor of the sponsor message;
a third step of providing the media product for sale at an Internet website;
a fourth step of restricting general public access to said media product;
a fifth step of offering to a consumer access to the media product without charge to the
consumer on the precondition that the consumer views the sponsor message;
18
Examples: Abstract Ideas
a sixth step of receiving from the consumer a request to view the sponsor message,
wherein the consumer submits said request in response to being offered access to the media
product;
a seventh step of, in response to receiving the request from the consumer, facilitating the
display of a sponsor message to the consumer;
an eighth step of, if the sponsor message is not an interactive message, allowing said
consumer access to said media product after said step of facilitating the display of said sponsor
message;
a ninth step of, if the sponsor message is an interactive message, presenting at least one
query to the consumer and allowing said consumer access to said media product after receiving a
response to said at least one query;
a tenth step of recording the transaction event to the activity log, said tenth step including
updating the total number of times the sponsor message has been presented; and
an eleventh step of receiving payment from the sponsor of the sponsor message
displayed.
Analysis
Claim 1: Ineligible.
The claim is directed to a process; i.e., a series of steps or acts, for distributing media and
advertisements over the Internet. A process is one of the statutory categories of invention (Step
1: YES).
The claim is then analyzed to determine whether it is directed to an exception. The claim recites
an eleven step process for displaying an advertisement in exchange for access to copyrighted
media. That is, the claim describes the concept of using advertising as an exchange or currency.
This concept is similar to the concepts involving human activity relating to commercial practices
(e.g., hedging in Bilski) that have been found by the courts to be abstract ideas. The addition of
limitations that narrow the idea, such as receiving copyrighted media, selecting an ad, offering
the media in exchange for watching the selected ad, displaying the ad, allowing the consumer
access to the media, and receiving payment from the sponsor of the ad, further describe the
abstract idea, but do not make it less abstract. The claim is directed to an abstract idea (Step 2A:
YES).
Next, the claim as a whole is analyzed to determine whether it amounts to significantly more
than the concept of using advertising as an exchange or currency. The claim has additional
limitations to the abstract idea such as accessing and updating an activity log, requiring a request
from the consumer to view the advertising, restricting public access, and using the Internet as an
information transmitting medium.
Viewing the limitations individually, the accessing and updating of an activity log are used only
for data gathering and, as such, only represent insignificant pre-solution activity. Similarly,
requiring a consumer request and restricting public access is insignificant pre-solution activity
because such activity is necessary and routine in implementing the concept of using advertising
as an exchange or currency; i.e., currency must be tendered upon request in order for access to be
19
Examples: Abstract Ideas
provided to a desired good. Furthermore, the Internet limitations do not add significantly more
because they are simply an attempt to limit the abstract idea to a particular technological
environment.
Viewing the limitations as a combination, the claim simply instructs the practitioner to
implement the concept of using advertising as an exchange or currency with routine,
conventional activity specified at a high level of generality in a particular technological
environment. When viewed either as individual limitations or as an ordered combination, the
claim as a whole does not add significantly more to the abstract idea of using advertising as an
exchange or currency (Step 2B: NO). The claim is not patent eligible.
20
Nature-Based Products
The following examples should be used in conjunction with the 2014 Interim Eligibility Guidance. They
replace the examples issued with the March 2014 Procedure For Subject Matter Eligibility Analysis Of
Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural
Products and related training. As the examples are intended to be illustrative only, they should be
interpreted based on fact patterns set forth below. Other fact patterns may have different eligibility
outcomes.
1. Gunpowder and Fireworks: Product Claims That Are Not Directed To An Exception
This example illustrates the application of the markedly different characteristics analysis to a nature-
based product produced by combining multiple components (claim 1), and also provides a sample of a
claimed product that when viewed as a whole is not nature-based, and thus is not subjected to the
markedly different characteristics analysis in order to determine that the claim is not directed to an
exception (claim 2).
Claims:
1. Gunpowder comprising: an intimate finely-ground mixture of 75% potassium nitrate, 15% charcoal
and 10% sulfur.
2. A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) the
gunpowder of claim 1, (d) a cardboard body having a first compartment containing the sparking
composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a
plastic ignition fuse having one end extending into the second compartment and the other end
extending out of the cardboard body.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Both
claims are directed to a statutory category, e.g., a composition of matter or manufacture (Step 1: YES).
Claim 1: Eligible. Because the claim is a nature-based product, i.e., a combination of three naturally
occurring substances (potassium nitrate, charcoal and sulfur), the nature-based product (the combination)
is analyzed to determine whether it has markedly different characteristics from any naturally occurring
counterpart(s) in their natural state. In this case, there is no naturally occurring counterpart to the claimed
combination (the components do not occur together in nature), so the combination is compared to the
individual components as they occur in nature. None of the three claimed substances are explosive in
nature. When the substances are finely-ground and intimately mixed in the claimed ratio, however, the
claimed combination is explosive upon ignition. This explosive property of the claimed combination is
markedly different from the non-explosive properties of the substances by themselves in nature.
Accordingly, the claimed combination has markedly different characteristics, and is not a “product of
nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible
subject matter.
Claim 2: Eligible. Although the claim recites two nature-based products (calcium chloride and
gunpowder), analysis of the claim as a whole indicates that the claim is focused on the assembly of
components that together form the firework, and not the nature-based products. Thus, it is not necessary
to apply the markedly different characteristics analysis in order to conclude that the claim is not directed
to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.
2. Pomelo Juice: Process Claim That Is Directed To An Exception And Product Claim That Is
Not Directed To An Exception
This example illustrates the eligibility analysis of a process (claim 1) that focuses on a nature-based
product and a product (claim 2) that is nature-based but is not directed to an exception because it has
markedly different characteristics from its naturally occurring counterpart.
1
Nature-Based Products
Background: The pomelo tree (Citrus maxima) is a naturally occurring tree that is native to South and
Southeast Asia. Pomelo fruit is often eaten raw or juiced, and has a mild grapefruit-like flavor. Naturally
occurring pomelo juice spoils over the course of a few days even when refrigerated, due to the growth of
bacteria that are naturally present in the juice. The specification indicates that suitable preservatives for
fruit juices are known in the art, and include naturally occurring preservatives such as vitamin E, and non-
naturally occurring preservatives such as preservative X. The specification defines an “effective amount”
of these preservatives as an amount sufficient to prevent juice from spoiling for at least three weeks, e.g.,
by retarding the growth of bacteria in the juice.
Claims:
1. A method comprising providing a pomelo fruit.
2. A beverage composition comprising pomelo juice and an effective amount of an added preservative.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All
of the claims are directed to a statutory category, e.g., a process or composition of matter (Step 1: YES).
Claim 1: Ineligible. Although the claim is a process claim, it has been drafted such that there is no
difference in substance from a product claim to the pomelo fruit itself. Accordingly, this process claim is
focused on the pomelo fruit per se (a nature-based product), and must be analyzed for markedly different
characteristics, to determine whether the claimed pomelo fruit is a “product of nature” exception. There is
no indication in the specification that the claimed fruit has any characteristics (structural, functional, or
otherwise) that are different from the naturally occurring fruit provided by pomelo trees. Thus, the
claimed fruit does not have markedly different characteristics from what occurs in nature, and is a
“product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because
the claim does not include any additional features that could add significantly more to the exception (Step
2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. §
101.
Claim 2: Eligible. Because the claim is a nature-based product, i.e., a combination of a naturally occurring
substance (pomelo juice) with an added preservative, the nature-based combination is analyzed to
determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in
their natural state. In this case, there is no naturally occurring counterpart to the claimed combination, so
the combination is compared to the individual components as they occur in nature. The specification
indicates that the preservative can be natural or non-natural in origin, but that regardless of its origin,
when an effective amount of preservative is mixed with the pomelo juice, the preservative affects the
juice so that it spoils much more slowly (spoils in a few weeks) than the naturally occurring juice by itself
(spoils in a few days). This property (slower spoiling) of the claimed combination is markedly different
from properties of the juice by itself in nature. Accordingly, the claimed combination has markedly
different characteristics, and is not a “product of nature” exception. Thus, the claim is not directed to an
exception (Step 2A: NO), and qualifies as eligible subject matter.
2
Nature-Based Products
Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon
basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in
treating breast and colon cancers. Many have tried and failed to isolate the cancer-fighting chemical from
the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has
named it amazonic acid. The purified amazonic acid is structurally and functionally identical to the
amazonic acid in the leaves. Applicant has created two derivatives of amazonic acid in the laboratory. The
first derivative (called 5-methyl amazonic acid), is structurally different from amazonic acid because a
hydrogen has been replaced with a methyl group, and is functionally different because it stimulates the
growth of hair in addition to treating cancer. The second derivative (called deoxyamazonic acid), was
created by removing a hydroxyl group from amazonic acid and replacing it with a hydrogen. Applicant
has not identified any functional difference between deoxyamazonic acid and amazonic acid.
Amazonic acid is absorbed through the lining of the human stomach and is rapidly metabolized by the
body. It is also insoluble in water. Applicants disclose an example of a solid pharmaceutical composition
demonstrating that when a core of amazonic acid is enveloped by a layer of a natural polymeric material,
the resulting manufacture does not release the amazonic acid until it reaches the colon. This colonic
release greatly improves the bioavailability of amazonic acid, and is particularly advantageous in the
treatment of colon cancer. The specification defines “natural polymeric material” as being a naturally
occurring polymer that is not easily digestible by human enzymes, so that it passes through most of the
human digestive system intact until it reaches the colon. Specific disclosed examples are shellac and
inulin. Applicants disclose an example of an aqueous composition, in which they were able to achieve a
stable solution of amazonic acid in water by including a solubilizing agent in the solution. The
solubilizing agent can be a naturally occurring product such as a sugar or polyol, or it can be a non-
naturally occurring product such as a polysorbate surfactant.
Claims:
1. Purified amazonic acid.
2. Purified 5-methyl amazonic acid.
3. Deoxyamazonic acid.
4. A composition comprising an acid produced by a process which comprises: providing amazonic acid;
and replacing the hydroxyl group of the amazonic acid with a hydrogen.
5. A pharmaceutical composition comprising: a core comprising amazonic acid; and a layer of natural
polymeric material enveloping the core.
6. A stable aqueous composition comprising: amazonic acid; and a solubilizing agent.
7. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid
to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said
daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.
8. A method of treating breast or colon cancer, comprising: administering an effective amount of
purified amazonic acid to a patient suffering from breast or colon cancer.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All
of the claims are directed to a statutory category, e.g., a composition of matter or process (Step 1: YES).
Because claims 1-6 are nature-based products (e.g., amazonic acid, 5-methyl amazonic acid, or
deoxyamazonic acid), the markedly different characteristics analysis is used to determine if the nature-
based products are exceptions. Although claims 7-8 recite nature-based products (amazonic acid), a full
eligibility analysis of these claims is not needed because the claims clearly do not seek to tie up all
practical uses of the nature-based products.
3
Nature-Based Products
Claim 1: Ineligible. Although applicant has discovered that amazonic acid naturally occurs in the leaves
of the Amazonian cherry tree, this discovery does not, by itself, render amazonic acid patent eligible.
Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013)
(“Myriad”). Instead, the claimed acid is analyzed to determine if separating the acid from its surrounding
material in the leaf has resulted in the purified amazonic acid having markedly different characteristics
from its naturally occurring counterpart. Based on the limited background information, there is no
indication that purified amazonic acid has any characteristics (structural, functional, or otherwise) that are
different from naturally occurring amazonic acid. The claim therefore encompasses amazonic acid that is
structurally and functionally identical to naturally occurring amazonic acid. Because there is no difference
between the claimed and naturally occurring acid, the claimed acid does not have markedly different
characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the
claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional
features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as
eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2: Eligible. The claimed 5-methyl amazonic acid has a different structural characteristic than
amazonic acid (its chemical structure is different due to the addition of the 5-methyl group). Because 5-
methyl amazonic acid is a unique molecule that is distinct from, and does not prevent others from using,
naturally occurring amazonic acid, its different structural characteristic rises to the level of a marked
difference. Accordingly, the claimed 5-methyl amazonic acid is not a “product of nature” exception. This
conclusion is bolstered by the fact that the different structural characteristic has resulted in a different
functional characteristic (the stimulation of hair growth). Thus, the claim is not directed to an exception
(Step 2A: NO), and qualifies as eligible subject matter.
Claim 3: Eligible. The claimed deoxyamazonic acid has a different structural characteristic from
amazonic acid (its chemical structure is different due to the removal of a hydroxyl group). Based on the
limited background information, this change in structure has not resulted in any different functional
characteristics. However, because deoxyamazonic acid is a unique molecule that is distinct from, and
does not prevent others from using, naturally occurring amazonic acid, its different structural
characteristic rises to the level of a marked difference. Accordingly, the claimed deoxyamazonic acid is
not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
Claim 4: Eligible. During examination, a product-by-process claim is not limited to manipulations of the
recited steps, but instead is only limited to the structure implied by the steps. In this case, the specification
describes that removing a hydroxyl group from amazonic acid and replacing it with a hydrogen results in
deoxyamazonic acid. Thus, the acid produced by the claimed process steps is deoxyamazonic acid. As
explained with respect to claim 3, deoxyamazonic acid has markedly different characteristics than
naturally occurring amazonic acid, and is not a “product of nature” exception. Thus, the claim is not
directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 5: Eligible. The claim is limited to a particular pharmaceutical composition having two naturally
occurring substances physically joined together into a non-natural structure (core of amazonic acid
surrounded by a layer of natural polymeric material). The claimed composition thus is structurally
different from the naturally occurring substances, and this structural difference results in the claimed
composition having different functional characteristics in vivo (e.g., amazonic acid is not released until
the composition reaches the colon, due to the relative indigestibility of the natural polymeric material,
thus increasing the bioavailability of the amazonic acid) than the naturally occurring substances by
themselves. These different structural and functional characteristics rise to the level of a marked
difference, and accordingly the claimed composition is not a “product of nature” exception. Thus, the
claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
4
Nature-Based Products
Claim 6: Eligible. In nature, amazonic acid is insoluble in water. As explained in the specification,
however, when amazonic acid is combined with a solubilizing agent, it becomes soluble in water and
forms a stable solution. This changed property (solubility) between amazonic acid as a part of the claimed
stable aqueous composition and amazonic acid in nature is a marked difference. Accordingly, the claimed
composition has markedly different characteristics, and is not a “product of nature” exception. Thus, the
claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 7: Eligible. Although the claim recites a nature-based product (amazonic acid), analysis of the
claim as a whole indicates that the claim is focused on a process of practically applying the product to
treat a particular disease (colon cancer), and not on the product per se. Thus, it is not necessary to apply
the markedly different characteristics analysis in order to conclude that the claim is not directed to an
exception (Step 2A: NO). The claim qualifies as eligible subject matter.
Claim 8: Eligible. Although the claim recites a nature-based product (amazonic acid), analysis of the
claim as a whole indicates that the claim is focused on a process of practically applying the product to
treat a particular disease (breast or colon cancer), and not on the product per se. Thus, it is not necessary
to apply the markedly different characteristics analysis in order to conclude that the claim is not directed
to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.
4. Purified Proteins
This example illustrates that changes in physical/chemical structure (claims 2-5) as compared to a
product’s natural counterpart can demonstrate markedly different characteristics, whether or not
accompanied by changes in biological/pharmacological function or chemical/physical properties.
Background: Newly discovered Streptomyces arizoneus bacteria produce Antibiotic L, which exhibits
antibiotic activity in nature (e.g., it kills other bacterial species in its natural environment). Naturally
occurring Antibiotic L is a protein that occurs in the form of hexagonal-pyramidal crystals (each crystal
has the shape of a six-sided pyramid) that are stored inside the bacteria. The specification describes
several processes that yield Antibiotic L having the same hexagonal-pyramidal crystal form as naturally
occurring Antibiotic L. The specification also discloses a process that yields purified Antibiotic L in the
form of tetrahedral crystals (each crystal has the shape of a tetrahedron or triangular pyramid). The
specification discloses that naturally occurring Antibiotic L has the amino acid sequence of SEQ ID NO:
2, and has a bacillosamine N-glycan on residue 49. In the specification, applicants describe recombinant
yeast that are able to synthesize Antibiotic L (naturally occurring yeast cannot synthesize Antibiotic L or
bacillosamine). Purified Antibiotic L expressed by these recombinant yeast has a high mannose (instead
of a bacillosamine) N-glycan on residue 49, and has lower immunogenicity to humans and a different
half-life in vivo than naturally occurring Antibiotic L. The specification defines “purified Antibiotic L” as
only being either Antibiotic L in the tetrahedral crystal form or Antibiotic L having a high mannose N-
glycan on residue 49.
Applicants disclose substitution modifications of Antibiotic L, e.g., peptides having one or more amino
acids substituted with different amino acids relative to SEQ ID NO: 2. No substitution modifications of
Antibiotic L are known to occur in nature. Some of the modifications result in altering the function of the
peptide, for example by increasing its ability to penetrate the cell membrane of a target organism. The
modified peptides have 90% or greater identity to SEQ ID NO: 2.
Claims:
1. Antibiotic L.
2. Purified Antibiotic L.
3. The Antibiotic L of claim 1, which is in a tetrahedral crystal form.
4. The Antibiotic L of claim 1, which is expressed by recombinant yeast.
5
Nature-Based Products
5. A purified antibiotic comprising an amino acid sequence that has at least 90% identity to SEQ ID NO:
2 and contains at least one substitution modification relative to SEQ ID NO: 2.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Because all of the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES),
and are nature-based products (Antibiotic L or a derivative thereof), the markedly different characteristics
analysis is used to determine if the nature-based products are exceptions.
Claim 1: Ineligible. As described in the specification, some Antibiotic L produced by the applicants is in
its naturally occurring hexagonal-pyramidal crystal form, while other Antibiotic L is in a non-natural
form, e.g., tetrahedral crystals. The claim thus encompasses antibiotic that is identical to the natural
antibiotic, and antibiotic that is changed. Because there is no difference in characteristics (structural,
functional, or otherwise) between the claimed and naturally occurring antibiotic for at least some of the
embodiments encompassed by the claim, the claimed Antibiotic L does not have markedly different
characteristics from what exists in nature, and thus is a “product of nature” exception. Accordingly, the
claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional
features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as
eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2: Eligible. Based on the specification’s definition of purified Antibiotic L, the claim is limited to
Antibiotic L in the form of tetrahedral crystals or having a high-mannose N-glycan on residue 49. The
claim does not encompass naturally occurring Antibiotic L (which forms hexagonal-pyramidal crystals,
and has a bacillosamine N-glycan on residue 49). The claimed antibiotic has particular structural/physical
characteristics that are different from the naturally occurring antibiotic (e.g., different crystalline form or
different N-glycan). The person of ordinary skill in the art would understand that these structural
differences may result in the claimed antibiotic having different functional characteristics (e.g., different
powder flow behavior or lower immunogenicity and different half-life) than the naturally occurring
antibiotic. These differences rise to the level of a marked difference, and thus the claimed antibiotic is not
a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
Claim 3: Eligible. The claim is limited to Antibiotic L in the form of tetrahedral crystals, and does not
encompass the naturally occurring hexagonal-pyramidal crystals. Although the claimed antibiotic is
chemically unchanged from nature, the claimed antibiotic has particular structural/physical characteristics
that are different from the naturally occurring antibiotic (e.g., different crystalline form). The person of
ordinary skill in the art would understand that these structural differences may result in the claimed
antibiotic having different functional characteristics (e.g., powder flow behavior) than the naturally
occurring antibiotic. These differences rise to the level of a marked difference, and thus the claimed
antibiotic is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A:
NO), and qualifies as eligible subject matter.
Claim 4: Eligible. During examination, a product-by-process claim is not limited to manipulations of the
recited steps, but instead is only limited to the structure implied by the steps. In this case, the specification
describes that Antibiotic L produced by recombinant yeast has a different structure (high-mannose N-
glycan) than the natural antibiotic (bacillosamine N-glycan). The claim is therefore limited to a
structurally different Antibiotic L having a high-mannose N-glycan. This structural difference results in a
change to the properties of the claimed antibiotic (lower immunogenicity and different half-life than the
natural antibiotic). These differences rise to the level of a marked difference, and thus the claimed
antibiotic is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A:
NO), and qualifies as eligible subject matter.
6
Nature-Based Products
Claim 5: Eligible. The claim is limited to peptides in which the amino acid sequence has at least 90%
identity to SEQ ID NO: 2, but has been changed to contain at least one non-naturally occurring
substitution modification relative to SEQ ID NO: 2. All of the claimed peptides have different structural
characteristics (e.g., one or more amino acids have been changed relative to the natural sequence). Some
of the claimed peptides may have different functional characteristics, but at least for some conservative
modifications there may be no observable functional difference. Because the structural differences
between the claimed peptides and their natural counterparts are enough to ensure that the claim is not
improperly tying up the future use of naturally occurring Antibiotic L, they rise to the level of a marked
difference, and thus the claimed antibiotic is not a “product of nature” exception. Thus, the claim is not
directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
7
Nature-Based Products
claimed bacterium is not a “product of nature” exception. Thus, the claim is not directed to an exception
(Step 2A: NO), and qualifies as eligible subject matter.
The bacterium of claim 2 was held to be patent-eligible subject matter in Diamond v. Chakrabarty, 447
U.S. 303 (1980). Recently, the Supreme Court looked back to this claim as an example of a nature-based
product that is patent-eligible because it has markedly different characteristics than naturally occurring
bacteria, as explained in Myriad, 133 S. Ct. at 2116-17:
In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break
down various components of crude oil. 447 U. S., at 305, 100 S. Ct. 2204, 65 L. Ed. 2d
144, and n. 1. The Court held that the modified bacterium was patentable. It explained
that the patent claim was “not to a hitherto unknown natural phenomenon, but to a
nonnaturally occurring manufacture or composition of matter--a product of human
ingenuity ‘having a distinctive name, character [and] use.’” Id., at 309-310, 100 S. Ct.
2204, 65 L. Ed. 2d 144 (quoting Hartranft v. Wiegmann, 121 U. S. 609, 615, 7 S. Ct.
1240, 30 L. Ed. 1012 (1887); alteration in original). The Chakrabarty bacterium was new
“with markedly different characteristics from any found in nature,” 447 U. S., at 310, 100
S. Ct. 2204, 65 L. Ed. 2d 144, due to the additional plasmids and resultant “capacity for
degrading oil.”
6. Bacterial Mixtures
This example illustrates the application of the markedly different characteristics analysis to nature-based
product claims produced by combining multiple components.
Background: Rhizobium bacteria are naturally occurring bacteria that infect leguminous plants such as
clover, alfalfa, beans and soy. Each species of bacteria will only infect certain types of plants, for example
R. meliloti will only infect alfalfa and sweet clover, and R. phaseoli will only infect garden beans. It was
assumed in the prior art that all Rhizobium species were mutually inhibitive, because prior art
combinations of different bacterial species produced an inhibitory effect on each other when mixed
together, with the result that their efficiency was reduced. Applicant has discovered that there are
particular strains of each Rhizobium species that do not exert a mutually inhibitive effect on each other,
and that these strains can be isolated and used in mixed cultures. Applicant has also discovered that
certain Rhizobium species, when mixed together, exhibit biological properties that are different than in
nature. For example, in nature or by itself, R. californiana will only infect lupine. When mixed with R.
phaseoli, however, R. californiana will infect both lupine and wild indigo. R. californiana and R. phaseoli
are not known to occur together in nature.
Claims:
1. An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains
of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in
respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
2. An inoculant for leguminous plants comprising a mixture of Rhizobium californiana and Rhizobium
phaseoli.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Because both claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and
are nature-based products (a mixture of bacteria), the markedly different characteristics analysis is used to
determine if the nature-based products are exceptions.
Claim 1: Ineligible. There is no indication in the specification that the claimed mixture of bacteria has any
characteristics (structural, functional, or otherwise) that are different from the naturally occurring
8
Nature-Based Products
bacteria. Thus, the mixture does not have markedly different characteristics from what occurs in nature,
and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES).
Because the claim does not include any additional features that could add significantly more to the
exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected
under 35 U.S.C. § 101.
The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 131 (1948):
Discovery of the fact that certain strains of each species of these bacteria can be mixed
without harmful effect to the properties of either is a discovery of their qualities of non-
inhibition. It is no more than the discovery of some of the handiwork of nature and hence
is not patentable. The aggregation of select strains of the several species into one product
is an application of that newly-discovered natural principle. But however ingenious the
discovery of that natural principle may have been, the application of it is hardly more
than an advance in the packaging of the inoculants. Each of the species of root-nodule
bacteria contained in the package infects the same group of leguminous plants which it
always infected. No species acquires a different use. The combination of species
produces no new bacteria, no change in the six species of bacteria, and no enlargement of
the range of their utility. Each species has the same effect it always had. The bacteria
perform in their natural way. Their use in combination does not improve in any way their
natural functioning. They serve the ends nature originally provided and act quite
independently of any effort of the patentee.
Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating
that “the composition was not patent eligible because the patent holder did not alter the bacteria in any
way.” Myriad, 133 S. Ct. at 2117.
Claim 2: Eligible. In nature, R. phaseoli only infects garden beans, and R. californiana only infects
lupine. When mixed together as claimed, the combination now infects a third species of plant: R.
californiana infects both lupine and wild indigo, but R. phaseoli continues to only infect garden beans.
The combination of species thus has changed R. californiana such that, when combined with R. phaseoli,
it has a different characteristic (biological function) than it had in nature, i.e., the claimed combination
infects a new group of leguminous plants (wild indigo) as compared to the naturally occurring bacteria by
themselves. This functional difference rises to the level of a marked difference, and accordingly the
claimed mixture is not a “product of nature” exception. Note that unless the examiner can show that this
particular mixture of bacteria exists in nature, this mere possibility does not bar the eligibility of this
claim. See, e.g., Myriad, 133 S. Ct. at 2119 n.8 (“The possibility that an unusual and rare phenomenon
might randomly create a molecule similar to one created synthetically through human ingenuity does not
render a composition of matter nonpatentable” (emphasis in original)). Thus, the claim is not directed to
an exception (Step 2A: NO), and qualifies as eligible subject matter.
7. Nucleic Acids
This example illustrates that changes in genetic information/structure (claims 2 and 4), or physical
structure (claim 3), as compared to a product’s natural counterpart can demonstrate markedly different
characteristics.
Background: Virginia nightshade is a naturally occurring plant that grows wild in the Shenandoah Valley
of Virginia. When damaged, the leaves of Virginia nightshade produce a hormone called Protein W,
which activates chemical defenses against herbivores. Protein W is naturally encoded by Gene W, which
is part of chromosome 3 in Virginia nightshade and has the nucleic acid sequence disclosed as SEQ ID
NO: 1. The specification also discloses substitution modifications of Gene W, e.g., nucleic acids having
one or more nucleotide bases that are substituted with different bases relative to SEQ ID NO: 1. For
9
Nature-Based Products
example, one of the disclosed modifications changes a naturally occurring adenine to a guanine, e.g., the
first nine nucleotides are “TAC GGG AAA” in naturally occurring Gene L and “TAC GGG AAG” in the
modified nucleic acid. Some of the modifications are silent, meaning that no change occurs in the
encoded protein. It is known in the art that some silent modifications affect characteristics of nucleic acid
such as transcription rate and splicing, and that some do not. No substitution modifications of Gene W are
known to occur in nature. The modified nucleic acids have 90% or greater identity to SEQ ID NO: 1. The
specification discloses labeling the nucleic acids, e.g., with a fluorescent or radioactive label.
The specification discloses vectors comprising SEQ ID NO: 1 and a heterologous nucleic acid. The
specification defines “heterologous” nucleic acid sequences as nucleic acid sequences that do not
naturally occur in Virginia nightshade, e.g., sequences from other plants, bacteria, viruses, or other
organisms. Disclosed heterologous nucleic acids include plant viral vectors such as tobacco mosaic virus,
and viral promoters such as the cauliflower mosaic virus (CaMV) 35S promoter. The viral promoters
cause different expression of Gene W as compared to its natural expression levels in Virginia nightshade,
e.g., Gene W is expressed all the time (constitutively) as opposed to only in response to leaf damage.
Claims:
1. Isolated nucleic acid comprising SEQ ID NO: 1.
2. Isolated nucleic acid comprising a sequence that has at least 90% identity to SEQ ID NO: 1 and
contains at least one substitution modification relative to SEQ ID NO: 1.
3. The isolated nucleic acid of claim 1, further comprising a fluorescent label attached to the nucleic
acid.
4. A vector comprising the nucleic acid of claim 1 and a heterologous nucleic acid sequence.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Because all of the claims are directed to a statutory category, e.g. a composition of matter (Step 1: YES),
and are nature-based products (a nucleic acid), the markedly different characteristics analysis is used to
determine if the nature-based products are exceptions.
Claim 1: Ineligible. The claimed nucleic acid has a different structural characteristic than naturally
occurring Gene W, because the chemical bonds at each end were severed in order to isolate it from the
chromosome on which it occurs in nature, but has the same nucleotide sequence as the natural gene. The
claimed nucleic acid has no different functional characteristics, i.e., it encodes the same protein as the
natural gene. Under the holding of Myriad, this isolated but otherwise unchanged nucleic acid is not
eligible because it is not different enough from what exists in nature to avoid improperly tying up the
future use and study of naturally occurring Gene W. In other words, the claimed nucleic acid is different,
but not markedly different, from its natural counterpart in its natural state (Gene W on chromosome 3),
and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A:
YES). Because the claim does not include any additional features that could add significantly more to the
exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected
under 35 U.S.C. § 101.
Claim 2: Eligible. The claim is limited to nucleic acids in which the nucleotide sequence has been
changed to contain at least one non-naturally occurring substitution modification relative to SEQ ID NO:
1. All of the claimed nucleic acids have different structural characteristics than the naturally occurring
nucleic acid, e.g., one or more nucleotides have been changed relative to the natural sequence. Some of
the claimed nucleic acids may have different functional characteristics, e.g., they may encode a different
protein than the natural gene. Because the structural differences between the claimed nucleic acids and
their natural counterparts are enough to ensure that the claim is not improperly tying up the future use of
naturally occurring Gene W, they rise to the level of a marked difference, and so the claimed nucleic acids
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Nature-Based Products
are not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
Claim 3: Eligible. The claim is limited to a molecule that includes a nucleic acid and a fluorescent label,
which combination does not occur in nature as a single molecule. The claimed molecule thus has different
structural characteristics than the naturally occurring nucleic acid and label (single molecule vs. two
separate molecules). It also has different functional characteristics (the labeled nucleic acid is now
fluorescent, whereas the natural gene is not). These differences rise to the level of a marked difference,
and so the claimed molecule is not a “product of nature” exception. Thus, the claim is not directed to an
exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 4: Eligible. The claim is limited to vectors comprising a non-natural combination of Gene W (SEQ
ID NO: 1) with a sequence from another organism, and thus does not read on the naturally occurring
chromosome in Virginia nightshade. This non-natural combination results in the vectors having a
different genetic structure and sequence than the naturally occurring nucleic acids, i.e., different structural
characteristics. Some of the claimed vectors may have different functional characteristics, depending on
the selected heterologous sequence. These differences rise to the level of a marked difference, and so the
claimed vector is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step
2A: NO), and qualifies as eligible subject matter.
8. Antibodies
This example illustrates that products created by human manipulation of natural processes (claims 2 and
3), as well as products that are changed in structure as compared to a product’s natural counterpart
(claims 4 and 5), can have markedly different characteristics.
Background: Newly discovered Staphylococcus texana bacteria have an antigen called Protein S on their
outer surface. The specification describes the discovery of naturally occurring antibodies to Protein S in
mice and wild coyotes living in Texas. No human antibodies to Protein S are naturally occurring.
Antibodies have two types of domains: (1) constant domains such as the Fc domain, which are unvarying
in antibodies of a particular class (e.g., IgA) within a species; and (2) variable domains comprising
complementarity determining regions (CDRs) that bind to an antigen and that vary from antibody to
antibody.
The specification describes multiple types of antibodies to Protein S, including:
murine antibodies, that were created by injecting laboratory mice with Protein S;
human antibodies, that were created by injecting transgenic mice with Protein S;
chimeric antibodies (defined as antibodies that have murine variable domains and human constant
domains);
humanized antibodies (defined as antibodies having murine CDRs but are otherwise human); and
antibodies with variant Fc domains (defined as antibodies having an Fc domain that is engineered
to comprise at least one amino acid modification relative to a wild-type Fc domain).
It is well-known in the art that murine antibodies have different constant domains than human and coyote
antibodies, and that murine antibodies may cause allergic reactions and anaphylactic shock when
administered to humans or coyotes. The specification discloses a particular murine antibody created by
applicants, comprising SEQ ID NOs: 7-12 as its six CDR sequences. There is no naturally occurring
antibody that has this particular combination of CDR sequences. It is well-known in the art that chimeric
and humanized antibodies are less immunogenic to humans than murine antibodies. It is also well-known
that antibodies with variant Fc domains may exhibit different characteristics (e.g., increased cytotoxicity
and/or serum half-life) than antibodies with wild-type Fc domains.
Claims:
1. An antibody to Protein S.
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antibodies. These differences rise to the level of a marked difference, and so the claimed antibodies are
not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
Claim 5: Eligible. The claim is limited to antibodies comprising a variant Fc domain, which is defined as
an Fc domain that is engineered to comprise at least one amino acid modification relative to a wild-type
Fc domain. The claimed antibodies have different structural characteristics (e.g., different amino acid
sequences and three-dimensional structures) than natural antibodies, and may also have different
functional characteristics (e.g., different cytotoxicity and/or serum half-life). These differences in
characteristics rise to the level of a marked difference, and so the claimed antibodies are not “product of
nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible
subject matter.
9. Cells
This example illustrates that a man-made product identical to a naturally occurring product does not
have markedly different characteristics (claim 1), but that changes in phenotype caused by human
manipulation can result in markedly different characteristics (claims 2 and 3). It also demonstrates the
application of the “significantly more” analysis to claims directed to a “product of nature” exception
(claims 4 and 5).
Background: Human stem cells are naturally occurring cells that can develop, through a process called
differentiation, into many different types of cells, such as cardiac cells, skin cells, and so on. Stem cells
have utility in regenerative medicine, which involves repairing diseased tissues or organs. One type of
diseased tissue that often needs repair is the heart’s pacemaker, which is formed from pacemaker cells
that generate electrical impulses to control heart rate. In nature, pacemaker cells can be identified via a
protein called marker P located on the cell surface. The pacemaker cells contain genes that are capable of
expressing a protein called marker Z, but in nature these genes are never expressed (there are no naturally
occurring pacemaker cells that have marker Z on their surface).
Applicant’s specification discloses differentiating stem cells into pacemaker cells, for use in regenerating
damaged heart tissue. Applicant discloses isolating stem cells from human volunteers, and then culturing
those cells in a particular growth medium in the presence of growth factor A, at various temperatures.
Isolation does not change the cells in any way, but applicant’s culture conditions cause the stem cells to
differentiate into pacemaker cells. Some of the man-made pacemaker cells produced by applicant are
genetically and phenotypically identical (e.g., express marker P) to naturally occurring pacemaker cells.
Other man-made pacemaker cells produced by applicant are genetically identical, but have a different
phenotype (e.g., express marker Z and exhibit increased efficiency in utilizing oxygen) than naturally
occurring pacemaker cells. Isolation of these man-made cells does not change them in any way.
The increased oxygen utilization efficiency of the pacemaker cells expressing marker Z is advantageous
in the regeneration of heart tissue in patients who are recovering from damage to the heart, such as that
caused by a myocardial infarction (heart attack). Applicant has discovered that a mixed population of
pacemaker cells that is about 10-15% positive for marker Z (i.e., about 10-15% of the cells in the
population express marker Z), and about 85-90% positive for marker P (i.e., about 85-90% of the cells in
the population express marker P), can be injected into a patient’s heart in order to regenerate a pacemaker
in vivo (in a patient’s body). This successful regeneration is possible because the cells interact with each
other to affect their growth rates, e.g., the cells expressing marker P grow faster in the mixed population
than when they are by themselves. However, a cell population with fewer (or no) cells expressing marker
Z is not capable of regenerating a pacemaker, because the cell population is starved of oxygen before it
can become established in the patient.
The specification discloses compositions including populations of pacemaker cells in containers, such as
flasks and petri dishes, which are routinely and conventionally used in laboratories to hold cells. Also
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Nature-Based Products
product, i.e., a combination of cells, the nature-based product (the population) is analyzed to determine
whether it has markedly different characteristics from any naturally occurring counterpart(s) in their
natural state. As discussed above with respect to claims 1 and 2, the cells expressing marker Z have
markedly different characteristics than naturally occurring cardiac pacemaker cells because of their
phenotypic differences, but the cells expressing marker P do not have markedly different characteristics
because they are identical to naturally occurring pacemaker cells. However, as described in the
specification, when these cells are mixed together in the claimed ratio to form the claimed population, the
cells interact with each other to affect their growth rates, e.g., the cells expressing marker P grow faster in
the mixed population than when they are by themselves. Naturally occurring pacemaker cells do not grow
at this rate in their natural state. This difference in biological properties (rate of cell growth) between the
claimed cell population and naturally occurring human pacemaker cells rises to the level of a marked
difference, and accordingly the claimed population is not a “product of nature” exception. Thus, the claim
is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 4: Ineligible. Because the claim recites a nature-based product, i.e., the population of cells, the
nature-based product is analyzed to determine whether it has markedly different characteristics from any
naturally occurring counterpart(s) in their natural state. As explained with respect to claim 1, isolated
man-made pacemaker cells do not have markedly different characteristics due to their isolation or human
manufacture. There is no indication in the specification that placing the cells in a generic container results
in the cells having any characteristics (structural, functional, or otherwise) that are different from the
naturally occurring cells in their natural state. Thus, the claimed population of cells does not have
markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
Accordingly, the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed
to determine whether any element, or combination of elements, is sufficient to ensure that the claim
amounts to significantly more than the exception. Although the claim recites a container, use of a
container to hold cells is not only well-understood, routine and conventional activity already engaged in
by the scientific community, it is also required for growing and using the cells. Additionally, the claim
recites the container at such a high level of generality that it merely tells a scientist to use whatever
container she wishes to use. Therefore, the claim as a whole adds nothing significantly more to the
“product of nature” itself. Thus, the claim does not amount to significantly more than the judicial
exception itself (Step 2B: NO). The claim does not qualify as eligible subject matter, and should be
rejected under 35 U.S.C. § 101.
Claim 5: Eligible. Because the claim is a nature-based product, i.e., a combination of cells and a scaffold,
the nature-based product (the combination) is analyzed to determine whether it has markedly different
characteristics from any naturally occurring counterpart(s) in their natural state. As explained with respect
to claim 1, isolated man-made pacemaker cells do not have markedly different characteristics due to their
isolation or human manufacture. There is also no indication in the specification that placing the cells into
a biocompatible three-dimensional scaffold results in the cells or the scaffold having any characteristics
(structural, functional, or otherwise) that are different from the naturally occurring cells or scaffold in
their natural state. Thus, the claimed population of cells, and the claimed scaffold, do not have markedly
different characteristics from what occurs in nature, and are “product of nature” exceptions. Accordingly,
the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed to determine
whether any element, or combination of elements, is sufficient to ensure that the claim amounts to
significantly more than the exception. The recitation of the biocompatible three-dimensional scaffold in
combination with the pacemaker cells is not required for growing or using the cells, because the cells can
be grown or used in other containers, and is not recited at a high level of generality. The addition of the
pacemaker cells to the scaffold confines the claim to a particular useful application of the scaffold (repair
of cardiac tissue), because the pacemaker cells are not routinely required for all practical uses of the
scaffold. Further, the combination of these elements does more than generally link these two judicial
exceptions together; as described in the specification, this combination improves the technology of
regenerative medicine, by facilitating faster tissue regeneration than when pacemaker cells are implanted
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Nature-Based Products
by themselves. Thus, the claim amounts to significantly more than the judicial exception itself (Step 2B:
YES), and qualifies as eligible subject matter.
10. Food
This example illustrates the difference between a nature-based product claim having multiple components
that are unchanged because they are not combined (claim 1), and a nature-based product claim having
multiple components that are changed by their combination (claim 2).
Background: Goats are naturally occurring animals that produce milk to feed their young. Humans have
consumed goat milk and products made from goat milk (e.g., cheese and yogurt) for centuries. One well-
known method of making goat yogurt is to create a starter culture by mixing raw goat milk with bacteria,
and then heating the starter culture to about 115 degrees Fahrenheit for several hours so that the bacteria
can ferment the milk. The fermentation causes the conversion of lactose (milk sugar) in the goat milk into
lactic acid, and this chemical change results in a physical change (the thickened consistency of the yogurt
as compared to the goat milk). The lactic acid also makes the yogurt have a tangy flavor. Multiple species
of bacteria are known as useful in making yogurt, including Streptococcus thermophilus (a naturally
occurring bacterial species).
Applicant has discovered a new naturally occurring bacterial species that it named Lactobacillus
alexandrinus. Goat milk yogurt made with L. alexandrinus has a pleasant tangy flavor. Neither S.
thermophilus nor L. alexandrinus occur naturally in goat milk, and these bacteria do not occur together in
nature. Applicant has also discovered that when mixed, S. thermophilus and L. alexandrinus have
different properties than either bacteria has alone: (1) the mixed bacteria act synergistically to ferment
goat milk at twice the speed than either bacteria can ferment by itself; and (2) the resultant goat yogurt is
much lower in fat than either bacteria can produce when used by itself. Applicant discloses compositions
comprising a goat milk starter comprising goat milk mixed with S. thermophilus and L. alexandrinus.
Applicant also discloses kits for preparing goat milk yogurt. The kits comprise a separate packet of S.
thermophilus, and a separate packet of L. alexandrinus, and may also comprise instructions for combining
the two bacterial species with goat milk to make yogurt.
Claims:
1. A kit for preparing goat milk yogurt comprising: Streptococcus thermophilus and Lactobacillus
alexandrinus.
2. A yogurt starter culture comprising: goat milk mixed with Streptococcus thermophilus and
Lactobacillus alexandrinus.
Analysis of Claims:
These claims have been analyzed for eligibility in accordance with their broadest reasonable
interpretation. Because both claims are directed to a statutory category, e.g., a composition of matter (Step
1: YES), and are nature-based products (goat milk and/or bacteria), the markedly different characteristics
analysis is used to determine if the nature-based products are exceptions.
Claim 1: Ineligible. As described in the specification, both S. thermophilus and L. alexandrinus are
naturally occurring bacteria. There is no indication in the specification that the claimed bacteria have any
characteristics (structural, functional, or otherwise) that are different from the naturally occurring
bacteria. Because the bacterial species in the kit are not mixed, but instead are separate from each other,
their inclusion in the same kit does not change their characteristics. Although the user of the kit may
choose to mix the bacteria together at some time in the future, that mixture, which may or may not exist in
the future is not a part of the claimed invention. In re Venezia, 530 F.2d 956, 958-59 (CCPA 1976). Thus,
the bacterial species in the kit do not have markedly different characteristics from their natural
counterparts in their natural state, and are “product of nature” exceptions. Accordingly, the claim is
directed to an exception (Step 2A: YES). Because the claim does not include any additional features that
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Nature-Based Products
could add significantly more to the exceptions (Step 2B: NO), the claim does not qualify as eligible
subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2: Eligible. As described in the specification, when S. thermophilus and L. alexandrinus are mixed,
the two bacterial species have different characteristics than either species does on its own, e.g., they act
together to ferment milk into a lower fat yogurt than either bacteria can produce when individually mixed
with the milk. Thus, the mixture of the bacteria and milk has different functional characteristics (lower fat
content) than the naturally occurring bacteria (or milk) by itself. These differences rise to the level of a
marked difference, and accordingly the claimed starter culture is not a “product of nature” exception.
Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
17
Streamlined Example 1
31
Streamlined Example 2
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July 2015 Update Appendix 1: Examples
The following examples should be used in conjunction with the 2014 Interim Guidance on
Subject Matter Eligibility (2014 IEG). As the examples are intended to be illustrative only,
they should be interpreted based on the fact patterns set forth below. Other fact patterns
may have different eligibility outcomes. While some of the fact patterns draw from U.S.
Supreme Court and U.S. Court of Appeals for the Federal Circuit decisions, each of the
examples shows how claims should be analyzed under the 2014 IEG. All of the claims are
analyzed for eligibility in accordance with their broadest reasonable interpretation.
Note that the examples herein are numbered consecutively beginning with number 21,
because 20 examples were previously issued. A comprehensive index of all examples for
use with the 2014 IEG is provided in Appendix 2 to the July 2015 Update.
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July 2015 Update Appendix 1: Examples
server. The server filters the stock quote information based upon the subscriber preference
information that is stored in memory on the server. That is, the server compares the
received stock quote information to the stored stocks of interest and stock price threshold
preferences to determine which stock quotes to drop and which to further process. Next, a
stock quote alert is built containing the filtered stocks’ name and price information and a
universal resource locator (URL) to a web page at the data source which contains further
information on the stock quote. The alert is then formatted into data blocks based upon the
alert format preference information. Subsequently, the formatted data blocks are
transmitted to the subscriber’s wireless device in accordance with the transmission
schedule. After receiving the alert, the subscriber can connect the wireless device to the
subscriber’s computer. The alert causes the subscriber’s computer to auto‐launch the stock
viewer application provided by the service to display the alert. When connected to the
Internet, the subscriber may then click on the URL in the alert to use the stock viewer
application to access more detailed information about the stock quote from the data
source.
Claims
1. A method of distributing stock quotes over a network to a remote subscriber computer,
the method comprising:
receiving stock quotes at a transmission server sent from a data source over the
Internet, the transmission server comprising a microprocessor and memory that stores the
remote subscriber’s preferences for information format, destination address, specified
stock price values, and transmission schedule, wherein the microprocessor
filters the received stock quotes by comparing the received stock quotes to the
specified stock price values;
generates a stock quote alert from the filtered stock quotes that contains a stock
name, stock price and a universal resource locator (URL), which specifies the location of
the data source;
formats the stock quote alert into data blocks according to said information format;
and
transmits the formatted stock quote alert to a computer of the remote subscriber
based upon the destination address and transmission schedule.
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July 2015 Update Appendix 1: Examples
the remote subscriber’s preferences for information format, destination address, specified
stock price values, and transmission schedule, wherein the microprocessor
filters the received stock quotes by comparing the received stock quotes to the
specified stock price values;
generates a stock quote alert from the filtered stock quotes that contains a stock
name, stock price and a universal resource locator (URL), which specifies the location of
the data source;
formats the stock quote alert into data blocks according to said information format;
and
transmits the formatted stock quote alert over a wireless communication channel to
a wireless device associated with a subscriber based upon the destination address and
transmission schedule,
wherein the alert activates the stock viewer application to cause the stock quote
alert to display on the remote subscriber computer and to enable connection via the URL to
the data source over the Internet when the wireless device is locally connected to the
remote subscriber computer and the remote subscriber computer comes online.
Analysis
Claim 1: Ineligible
The claim recites a series of acts for distributing stock quotes to selected remote devices.
Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES).
Next, the claim is analyzed to determine whether it is directed to a judicial exception. The
claim recites the steps of receiving, filtering, formatting and transmitting stock quote
information. In other words, the claim recites comparing and formatting information for
transmission. This is simply the organization and comparison of data which can be
performed mentally and is an idea of itself. It is similar to other concepts that have been
identified as abstract by the courts, such as using categories to organize, store and transmit
information in Cyberfone, or comparing new and stored information and using rules to
identify options in SmartGene. Therefore, the claim is directed to an abstract idea (Step 2A:
YES).
Next, the claim as a whole is analyzed to determine whether any element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the
exception. The claim recites the additional limitations of using a transmission server with a
memory that stores subscriber preferences, a transmitter that receives and sends
information over the Internet, and a microprocessor that performs the generic functions of
comparing and formatting information. The transmission server is recited at a high level of
generality and its broadest reasonable interpretation comprises only a microprocessor,
memory and transmitter to simply perform the generic computer functions of receiving,
processing and transmitting information. Generic computers performing generic computer
functions, alone, do not amount to significantly more than the abstract idea. Finally, the
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July 2015 Update Appendix 1: Examples
Internet limitations are simply a field of use that is an attempt to limit the abstract idea to a
particular technological environment and, so do not add significantly more. Viewing the
limitations as an ordered combination does not add anything further than looking at the
limitations individually. When viewed either individually, or as an ordered combination,
the additional limitations do not amount to a claim as a whole that is significantly more
than the abstract idea (Step 2B: NO). The claim is not patent eligible.
A rejection of claim 1 should identify the exception by pointing to the filtering, generating
and formatting steps and explain that the comparing and formatting of information is a
mental process that is similar to the concepts that courts have previously found abstract.
The rejection should also identify the additional limitations regarding the transmission
server and explain why those limitations comprise only a generic computer performing
generic computer functions that do not impose meaningful limits on the claimed method.
Claim 2: Eligible
The claim recites a series of acts for distributing stock quotes to selected remote devices.
Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES).
The claim is then analyzed to determine if the claim is directed to a judicial exception. As
discussed above, the recited steps of comparing and organizing data for transmission are a
mental process and similar to other concepts found to be abstract by the courts. The claim
is directed to an abstract idea (Step 2A: YES).
Next, the claim as a whole is evaluated to determine if there are additional limitations that
amount to significantly more than the abstract idea. The claim recites the additional
limitations of using a transmission server with a microprocessor and a memory to store
subscriber preferences, transmitting a stock quote alert from the transmission server over
a data channel to a wireless device, and providing a stock viewer application that causes
the stock quote alert to display on the subscriber computer and enables a connection from
the subscriber computer to the data source over the Internet when the subscriber
computer comes online. It is noted that, as discussed above, some of the limitations when
viewed individually do not amount to significantly more than the abstract idea (such as
storing subscriber preferences or transmitting an alert). However, when looking at the
additional limitations as an ordered combination, the invention as a whole amounts to
significantly more than simply organizing and comparing data. The claimed invention
addresses the Internet‐centric challenge of alerting a subscriber with time sensitive
information when the subscriber’s computer is offline. This is addressed by transmitting
the alert over a wireless communication channel to activate the stock viewer application,
which causes the alert to display and enables the connection of the remote subscriber
computer to the data source over the Internet when the remote subscriber computer
comes online. These are meaningful limitations that add more than generally linking the
use of the abstract idea (the general concept of organizing and comparing data) to the
Internet, because they solve an Internet‐centric problem with a claimed solution that is
necessarily rooted in computer technology, similar to the additional elements in DDR
Holdings. These limitations, when taken as an ordered combination, provide
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July 2015 Update Appendix 1: Examples
unconventional steps that confine the abstract idea to a particular useful application.
Therefore, the claim recites patent eligible subject matter (Step 2B: YES).
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that the claim recites the
abstract idea of comparing and organizing data for transmission. However, the claim is
eligible because it recites additional limitations that when considered as an ordered
combination demonstrates a technologically rooted solution to an Internet‐centric problem
and thus amounts to significantly more than comparing and organizing information for
transmission.
Claim
2. A system of computerized meal planning, comprising:
a User Interface;
a Database of food objects; and
a Meal Builder, which displays on the User Interface meals from the Database and
wherein a user can change content of said meals and view the resulting meals’ impact on
customized eating goals.
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July 2015 Update Appendix 1: Examples
Analysis
Claim 2: Ineligible.
The broadest reasonable interpretation of the claim encompasses a computer system (e.g.,
hardware such as a processor and memory) that implements a user interface, a database,
and a food data selection program. The system comprises a device or set of devices and,
therefore, is directed to a machine, which is a statutory category of invention (Step 1: YES).
The claim is then analyzed to determine if the claim is directed to a judicial exception. The
claim recites a system for selecting and modifying meals based upon dietary goals. In other
words, the claim describes a process of meal planning. Meal planning is the organization
and comparison of information to develop a guideline for eating. It is a mental process of
managing behavior that could be performed in the human mind, or by a human using a pen
and paper. Such a basic concept is similar to other mental processes found abstract by the
courts such as comparing new and stored information and using rules to identify options in
SmartGene, and obtaining and comparing intangible data in Cybersource. Therefore, claim 2
is directed to an abstract idea (Step 2A: YES).
Next, the claim is analyzed to determine if there are additional claim limitations that
individually, or as an ordered combination, ensure that the claim amounts to significantly
more than the abstract idea. The only additional limitations in the claim relate to
computerization of meal planning with an interface, a database of food objects, and a “meal
builder,” which is a computer program that allows selection and comparison of food data.
The meal builder would require a processor and memory in order to perform basic
computer functions of accepting user input, retrieving information from a database,
manipulating that information and displaying the results. These components are not
explicitly recited and therefore must be construed at the highest level of generality. The
interface is also recited at a high level of generality with the only required function of
displaying, which is a well‐known routine function of interfaces. Further, the database
performs only its basic function of storing information, which is common to all databases.
Thus, the recited generic computer components perform no more than their basic
computer functions. These additional elements are well‐understood, routine and
conventional limitations that amount to mere instructions to implement the abstract idea
of meal planning on a computer. Taking these computer limitations as an ordered
combination adds nothing that is not already present when the elements are taken
individually. Therefore, the claim does not amount to significantly more than the recited
abstract idea (Step 2B: NO). The claim is not patent eligible.
A rejection of this claim should identify the abstract idea of selecting meals for a
customized eating goal, which is similar to concepts of obtaining and comparing data that
were found to be abstract by the courts. The rejection should also identify the additional
elements and explain the reasons why they amount to no more than merely implementing
the idea of meal planning using generic computer components.
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July 2015 Update Appendix 1: Examples
7
July 2015 Update Appendix 1: Examples
Claims
1. A computer‐implemented method for dynamically relocating textual information within
an underlying window displayed in a graphical user interface, the method comprising:
displaying a first window containing textual information in a first format within a
graphical user interface on a computer screen;
displaying a second window within the graphical user interface;
constantly monitoring the boundaries of the first window and the second window to
detect an overlap condition where the second window overlaps the first window such that
the textual information in the first window is obscured from a user’s view;
automatically relocating the textual information, by a processor, to an unobscured
portion of the first window in a second format during an overlap condition so that the
textual information is viewable on the computer screen by the user; and
automatically returning the relocated textual information, by the processor, to the
first format within the first window when the overlap condition no longer exists.
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July 2015 Update Appendix 1: Examples
constantly monitoring the boundaries of the first window and the second window to
detect an overlap condition where the second window overlaps the first window such that
the textual information in the first window is obscured from a user’s view;
determining the textual information would not be completely viewable if relocated
to an unobstructed portion of the first window;
calculating a first measure of the area of the first window and a second measure of
the area of the unobstructed portion of the first window;
calculating a scaling factor which is proportional to the difference between the first
measure and the second measure;
scaling the textual information based upon the scaling factor;
automatically relocating the scaled textual information, by a processor, to the
unobscured portion of the first window in a second format during an overlap condition so
that the entire scaled textual information is viewable on the computer screen by the user;
and
automatically returning the relocated scaled textual information, by the processor,
to the first format within the first window when the overlap condition no longer exists.
Analysis
Claim 1: Eligible.
The claim recites a series of steps for relocating textual information in an underlying
window to an unobscured portion of the underlying window. Thus, the claim is directed to
a process, which is one of the statutory categories of invention (Step 1: YES).
Next, the claim must be analyzed to determine whether it is directed to a judicial exception.
Here, the claimed method relates to addressing a problem with overlapping windows
within a graphical user interface. In particular, the claim recites dynamically relocating
textual information within a window displayed in a graphical user interface based upon a
detected overlap condition. When the windows overlap, textual information is reformatted
and relocated to an unobscured portion of the underlying window; when the windows no
longer overlap, the textual information is returned to its original format and location. The
claim does not recite a basic concept that is similar to any abstract idea previously
identified by the courts. For example, the claim does not recite any mathematical concept
or a mental process such as comparing or categorizing information that can be performed
in the human mind, or by a human using a pen and paper. Accordingly, the claim does not
set forth or describe an abstract idea. Instead, the claimed method is necessarily rooted in
computer technology to overcome a problem specifically arising in graphical user
interfaces. Additionally, the claim does not recite any other judicial exception. Therefore,
the claim is not directed to a judicial exception (Step 2A: NO). The claim is patent eligible.
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that the claim is not directed
to any judicial exception.
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July 2015 Update Appendix 1: Examples
Claim 2: Ineligible.
The claim is directed to a series of steps for calculating a scaling factor, and thus is a
process which is a statutory category of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exceptions.
The claim recites the steps of calculating a first area and a second area and using the areas
to calculate a scaling factor. This concept is similar to the other types of basic concepts that
have been found by the courts to be abstract. In particular, the courts have found
mathematical algorithms to be abstract ideas (e.g., a mathematical procedure for
converting one form of numerical representation to another in Benson, or an algorithm for
calculating parameters indicating an abnormal condition in Grams). Therefore, the claim is
directed to an abstract idea (Step 2A: YES).
Next, the claim is analyzed to determine whether there are additional limitations recited in
the claim that amount to significantly more than the abstract idea, either individually or as
an ordered combination. The body of the claim does not recite any additional limitations
besides the mathematical algorithm for calculating a scaling factor. However, the preamble
of the claim does provide the additional limitations that the process is computer‐
implemented and textual information is contained in a window in a graphical user
interface. These limitations indicate the claimed process is used in a graphical user
interface environment. Where the preamble only states the purpose or the field of use of
an invention, the preamble does not limit the scope of the claim. Such a limitation does not
give “life, meaning and vitality to the claim.” (See MPEP 2111.02.) Therefore, the
limitations in the preamble do not limit the claim and there are no additional limitations
beyond the mathematical algorithm. Therefore, the claim does not amount to significantly
more than the abstract idea itself (Step 2B: NO). The claim is not patent eligible.
A rejection of claim 2 should identify the exception by pointing to the generating and
scaling steps and explain that the steps are a mathematical algorithm similar to those found
by the courts to be abstract. The rejection should also note that the preamble does not
limit the scope of the claim and, therefore, there are no additional limitations in the claim
besides the abstract idea.
Claim 3: Ineligible.
The claim is directed to a series of steps for calculating a scaling factor, and thus is a
process which is a statutory category of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exceptions.
The claim recites the steps of calculating a first area and a second area and using the areas
to calculate a scaling factor. As discussed above, these steps describe a mathematical
algorithm which has been found by the courts to be an abstract idea. Therefore, the claim
is directed to an abstract idea (Step 2A: YES).
The claim is then analyzed to determine whether it is directed to any judicial exceptions.
The claim recites that the step of calculating a scaling factor is performed by “the
computer” (referencing the computer recited in the preamble). Such a limitation gives “life,
meaning and vitality” to the preamble and, therefore, the preamble is construed to further
limit the claim. (See MPEP 2111.02.) Thus, the claim recites the additional limitations that
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July 2015 Update Appendix 1: Examples
Claim 4: Eligible.
As discussed above, the claim recites a series of acts and thus is a process (Step 1: YES).
Next, the claim is evaluated to determine if the claim is directed to a judicial exception. The
claim recites similar steps to those recited in claim 2; notably calculating a first measure of
the area of a first window and a second measure of the area of the unobstructed portion of
the first window and calculating a scaling factor that is proportional to the difference
between the first and second measure. As explained with regards to claim 2, the courts
have previously found mathematical algorithms to be abstract ideas. Therefore, the claim
is directed to an abstract idea (Step 2A: YES).
The claim must be analyzed to determine if the claim recites additional limitations that
amount to significantly more than the abstract idea. The claim recites the additional
limitations of a computer screen and processor. The recitation of the computer screen for
displaying and the processor for moving data is not enough by itself to transform the
exception into a patentable invention, because these limitations are generic computer
components performing generic computer functions at a high level of generality. Merely
using these generic computer components to perform the identified basic functions does
not constitute meaningful limitations that would amount to significantly more than the
abstract idea.
However, when viewing these computer limitations as an ordered combination with the
remaining limitations, the claim amounts to significantly more than the abstract idea. The
claim further recites the limitations of displaying a first and second window, detecting an
overlap condition indicating the windows overlap such that textual information in the first
window is obscured from view, determining the textual information is too large to fit in an
unobstructed portion of the first window, scaling the textual information based upon the
calculated scale factor, automatically relocating the scaled textual information to an
unobstructed portion of the first window so that it is viewable by the user, and
automatically returning the textual information to its original format when the overlap
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July 2015 Update Appendix 1: Examples
condition no longer exists. These limitations are not merely attempting to limit the
mathematical algorithm to a particular technological environment. Instead, these claim
limitations recite a specific application of the mathematical algorithm that improves the
functioning of the basic display function of the computer itself. As discussed above, the
scaling and relocating the textual information in overlapping windows improves the ability
of the computer to display information and interact with the user.
Taking all the claim elements both individually and as an ordered combination, the claim as
a whole amounts to significantly more than the mathematical algorithm of calculating a
scaling factor (Step 2B: YES). Thus, the claim recites patent eligible subject matter.
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that the claim recites a
mathematical algorithm which is an abstract idea. However, the claim is eligible because it
recites additional limitations that when considered as an ordered combination
demonstrate an improvement to the computer’s basic ability to display information and
interact with the user.
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July 2015 Update Appendix 1: Examples
Using the formulae, an operator can calculate an updated alarm limit once he knows the
original alarm base, the appropriate margin of safety, the time interval that should elapse
between each updating, the current temperature (or other process variable), and the
appropriate weighting factor to be used to average the original alarm base and the current
temperature. The formulae for updating alarm limits are used in a catalytic conversion
processing system; however, applicant’s specification contains no disclosure relating to
that system, such as the chemical processes at work, the monitoring of process conditions,
the determination of variables in the formulae from process conditions, or the means of
setting off an alarm or adjusting an alarm system. Applicant’s specification makes it clear
that the method is implemented on a computer for automatic adjustment of alarm settings.
Claim
1. A method for updating the value of at least one alarm limit on at least one process
variable involved in a process comprising the catalytic chemical conversion of
hydrocarbons wherein said alarm limit has a current value of B0+K wherein B0 is the
current alarm base and K is a predetermined alarm offset which comprises:
(1) Determining the present value of said process variable, said present value being
defined as PVL;
(2) Determining a new alarm base B1, using the following equation:
B1= B0(1.0‐F) + PVL(F)
where F is a predetermined number greater than zero and less than 1.0;
(3) Determining an updated alarm limit which is defined as B1+K; and thereafter
(4) Adjusting said alarm limit to said updated alarm limit value.
Analysis
Claim 1: Ineligible.
The claim is analyzed for eligibility in accordance with its broadest reasonable
interpretation, which here covers performance of the method by hand or by a computer.
The claim recites a series of acts including determining the value of a process variable,
calculating a new alarm base and an updated alarm limit, and adjusting the alarm limit to
the updated alarm limit value. Thus, the claim is directed to a process, which is one of the
statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception.
The claim recites a formula for updating alarm limits that comprises the limitations of
calculating the alarm base using the mathematical formula B1= B0(1.0‐F) + PVL(F), and then
calculating the updated alarm limit (UAV) using the mathematical formula UAV=B1+K.
These limitations set forth a judicial exception, because mathematical relationships have
been characterized by the courts as abstract ideas (e.g., the mathematical formula in
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July 2015 Update Appendix 1: Examples
Mackay Radio). It should be noted that in this case, the formula is novel, yet is an abstract
idea. Thus, the claim is directed to an exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine whether any element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the
exception. The claim recites additional elements/steps of determining the value of an
unspecified process variable involved in catalytic chemical conversion of hydrocarbons and
adjusting the alarm limit to the calculated updated alarm limit value. The preamble
specifies the field of use, which is catalytic conversion of hydrocarbons, but in this case
imposes no limits on the process of calculating an alarm limit value using the specified
equation.
Taken alone, none of the additional elements amounts to significantly more than the
exception. Determining the value of an unspecified process variable is mere data gathering
and the claimed adjusting the alarm limit to an updated limit is mere post‐solution activity
that could be attached to almost any formula. By failing to explain how the process variable
is selected, integrate the formula into any specified chemical processes at work in the
catalytic conversion, or specify the means of setting off an alarm or adjusting the alarm
limit, the claim fails to improve the recited technological field. The steps merely calculate a
result using a novel equation and do not add any meaningful limits on use of the equation.
Taken alone or as an ordered combination, these additional elements do not amount to a
claim as a whole that is significantly more than the exception. (Step 2B: NO). The claim is
not eligible.
For purposes of discussion, it is noted that if the broadest reasonable interpretation of this
claim were limited to a computer implementation, adding a generic computer to perform
generic functions that are well‐understood, routine and conventional, such as gathering
data, performing calculations, and outputting a result would not transform the claim into
eligible subject matter. Generic computer‐implementation of the method is not a
meaningful limitation that alone can amount to significantly more than the exception.
Moreover, when viewed as a whole with such additional elements considered as an
ordered combination, the claim modified by adding a generic computer would be nothing
more than a purely conventional computerized implementation of applicant’s formula in
the general field of industrial chemical processing and would not provide significantly
more than the judicial exception itself.
A rejection of claim 1 should identify the exception by pointing to the formula in the claim
and explain that the formula is a mathematical relationship similar to those found by the
courts to be abstract. The rejection should also identify the additional elements in the
claim and explain why they do not amount to significantly more, in this case, because they
merely add data gathering and a field of use.
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July 2015 Update Appendix 1: Examples
1 recites a method that is directed to a mathematical relationship and steps that could be
performed mentally and has additional elements/steps that amount to significantly more
than the abstract ideas because as a whole they transform a particular article to a different
state or thing and use the abstract ideas to improve another technology/technical field, either
of which can show eligibility. Claim 2 is a hypothetical claim in the form of computerized
instructions. Claim 2, which also is directed to the mathematical relationship and steps that
could be performed mentally, is eligible due to the additional elements/steps that use the
abstract ideas to improve another technology/technical field.
Background
Applicant has invented a process of controlling a rubber molding press with a computer to
precisely shape uncured material under heat and pressure and then cure the synthetic
rubber in the mold to obtain a product that retains its shape. Raw (uncured) synthetic
rubber comprises independent polymeric chains, e.g., a mixture of isobutylene and
isoprene polymers. Curing cross‐links the polymeric chains together, thereby changing the
rubber from its raw state into a more durable form that will retain a molded shape. Proper
curing depends upon several factors including the thickness of the article to be molded, the
temperature of the molding process, and the amount of time that the article is allowed to
remain in the press.
At the time of applicant’s invention, the usual way of operating rubber‐molding presses is
for the operator to load and close the press manually. Closure of the press operates a timer
that is preset for an estimated cure time. Due to the manual operation, the actual mold
temperature may vary, and result in overcured or undercured rubber because the preset
time is not equivalent to the actual time required for proper curing.
In the instant application, applicant’s process improves upon conventional molding
processes by constantly measuring the actual temperature inside the mold using a
thermocouple, and automatically feeding these temperature measurements into a standard
digital computer that repeatedly recalculates the cure time by use of the Arrhenius
equation. The Arrhenius equation has long been used to calculate the cure time in rubber‐
molding processes, and can be expressed as ln v = CZ+x, where ln is natural logarithm
conversion data, v is the total required cure time, C is the activation energy constant unique
to each batch of said compound being molded, Z is the temperature of the mold, and x is a
constant dependent upon the geometry of the particular mold of the press. When the
recalculated time equals the actual time that has elapsed since the press was closed, the
computer signals a device to open the press. Applicant’s process obtains uniformly accurate
cures, which results in substantially reducing the number of defectively cured batches that
must be discarded. The improved process also substantially reduces the amount of time in
which the presses are closed unnecessarily, thereby resulting in more efficient employment
of the mold and operator.
Claims
1. A method of operating a rubber‐molding press for precision molded compounds with
the aid of a digital computer, comprising:
providing said computer with a data base for said press including at least, natural
logarithm conversion data (ln), the activation energy constant (C) unique to each batch of
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July 2015 Update Appendix 1: Examples
said compound being molded, and a constant (x) dependent upon the geometry of the
particular mold of the press,
initiating an interval timer in said computer upon the closure of the press for
monitoring the elapsed time of said closure,
constantly determining the temperature (Z) of the mold at a location closely
adjacent to the mold cavity in the press during molding,
constantly providing the computer with the temperature (Z),
repetitively calculating in the computer, at frequent intervals during each cure, the
Arrhenius equation for reaction time during the cure, which is ln v = CZ+x, where v is the
total required cure time,
repetitively comparing in the computer at said frequent intervals during the cure
each said calculation of the total required cure time calculated with the Arrhenius equation
and said elapsed time, and
opening the press automatically when a said comparison indicates equivalence.
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July 2015 Update Appendix 1: Examples
Analysis
Claim 1: Eligible.
The claim recites a series of acts including determining the temperature of the mold and
providing that temperature to the computer. Thus, the claim is directed to a process, which
is one of the statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception.
The claim recites a limitation of repetitively calculating the Arrhenius equation (the
mathematical formula: ln v = CZ+x) for reaction time during the cure. This limitation sets
forth a judicial exception, because calculating the reaction time using the Arrhenius
equation is a mathematical relationship that the courts have held is representative of a law
of nature (e.g., the mathematical formula in Flook). Mathematical relationships such as this
have also been characterized by the courts as abstract ideas. Additionally, the claim
limitations of performing repetitive calculations and comparisons between the calculated
time and the elapsed time could be performed by a human using mental steps or basic
critical thinking, which are types of activities that have also been found by the courts to
represent abstract ideas (e.g., the mental comparison in Ambry Genetics). Thus, the claim is
directed to at least one exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine whether any additional element, or
combination of elements, is sufficient to ensure that the claim amounts to significantly
more than the exceptions (the mathematical relationship and the critical thinking steps of
calculating and comparing). Since there are multiple abstract ideas recited in the claim, the
Step 2B analysis needs to be conducted for each abstract idea individually, until the
analysis shows ineligibility for one or eligibility for all.
The Step 2B analysis is first conducted for the mathematical relationship. Besides the
mathematical relationship, the claim recites additional elements of providing a digital
computer with a data base of values, initiating an interval timer, constantly determining the
temperature of the mold, constantly providing the computer with the temperature, using
the computer to perform the calculations and comparisons, and opening the press
automatically when the comparison indicates equivalence. Some of the additional
elements/steps, such as accessing a database and using a computer to perform calculations
and comparisons, are routine computer activities or generic functions performed by a
computer that taken alone do not add significantly more to the process instructions in the
claim. By themselves, these limitations are recited at a high level of generality and perform
the basic functions of a computer that are well‐understood, routine and conventional (e.g.,
accessing a data base to receive and store data, and performing mathematical operations
on a computer). Likewise, initiating a timer and determining a temperature, taken alone,
are mere data gathering steps to obtain data necessary to calculate the time using the
Arrhenius equation.
However, when viewing the claim as a whole, the combination of all these steps taken
together, including the constant determination of the temperature of the mold, the
repetitive calculations and comparisons, and the opening of the press based on the
calculations, amount to significantly more than simply calculating the mold time using the
Arrhenius equation because they add meaningful limits on use of the equation. The claim
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July 2015 Update Appendix 1: Examples
does not merely recite the equation in isolation, but integrates these ideas into the molding
process. The additional steps specifically relate to the particular variables used, how the
variables are gathered, the process by which the rubber is molded and cured, and how the
result of the cure time calculation is used. The totality of the steps act in concert to
improve another technical field, specifically the field of precision rubber molding, by
controlling the operation of the mold. In addition, the claimed steps taken as a combination
effect a transformation of the raw, uncured synthetic rubber into a different state or thing,
i.e., a cured and molded rubber product. Thus, the claim amounts to significantly more than
the mathematical relationship (i.e., the abstract idea of the Arrhenius equation).
Because the claim is eligible with respect to the first abstract idea, it is expected that the
additional limitations will amount to significantly more than the second abstract idea (the
critical thinking steps of calculating and comparing). This is true in this example. The
additional limitations discussed above are significantly more than the critical thinking
skills of calculating and comparing results. As previously stated, evaluating the additional
limitations both individually and as an ordered combination demonstrates that the claim
improves the technical field of precision rubber molding and transforms the raw, uncured
synthetic rubber into a different state or thing. Taking all the claim elements both
individually and as an ordered combination, the claim as a whole amounts to significantly
more than the abstract ideas (Step 2B: YES). The claim recites patent eligible subject
matter.
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that the claim recites
exceptions including the Arrhenius equation, which is a law of nature or abstract idea.
However, the claim is eligible because it recites additional limitations that when considered
as an ordered combination provide meaningful limits on the use of the equation and
improve the technical field of precision rubber molding.
Claim 2: Eligible.
The claim recites a non‐transitory computer‐readable medium with stored instructions
that are used to control a rubber molding press. The claim is directed to a manufacture (an
article produced from materials), which is a statutory category of invention (Step 1: YES).
Note that the term “non‐transitory” ensures the claim does not encompass signals and
other non‐statutory transitory forms of signal transmission.
The claim recites the same steps of performing repetitive calculations of the reaction time
using the Arrhenius equation and comparing the results as claim 1, albeit in the form of
computer executable instructions. Therefore, the claim is directed to the same abstract
ideas identified in claim 1 (Step 2A: YES).
Conducting the Step 2B analysis for the first abstract idea (the Arrhenius equation), the
claim recites additional elements including computer instructions to access a database,
initiate an interval timer, constantly receive data, and initiate a signal to control the press.
The steps also include computer instructions to implement the equation. While some of the
elements taken alone are well‐understood, routine and conventional use of a computer, or
mere data gathering, the combination of the additional elements when the claim is viewed
as a whole amounts to significantly more than simply calculating the mold time using the
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July 2015 Update Appendix 1: Examples
Arrhenius equation. The totality of the steps governed by the claimed instructions provides
software that improves another technical field, specifically the field of precision rubber
molding, through controlling the operation of the mold by initiating a signal to control the
press to open when the comparison indicates equivalence and the molded product is cured.
This software enhances the ability of a specific rubber molding device to open the press at
the optimal time for curing the rubber therein. This process does not merely link the
Arrhenius equation to a technical field, but adds meaningful limitations on the use of the
mathematical relationship by specifying the types of variables used (temperature and
time), how they are selected (their relationship to the reaction time), how the process uses
the variables in rubber molding, and how the result is employed to improve the operation
of the press. For at least these reasons, the elements/steps recited in addition to the
mathematical formula, particularly taken in combination, show that claim 2 is not directed
to instructions to use the formula in isolation, but rather integrate the concept into an
eligible control scheme to improve another technological process.
Similarly, the claim recites additional limitations that when viewed as an ordered
combination amount to significantly more than the second abstract idea (the critical
thinking steps of calculating and comparing the timing data). As already discussed, these
additional limitations demonstrate an improvement in the field of precision rubber
molding technology and amount to more than simple instructions to perform the
calculating/comparing steps in isolation. Thus, the claim amounts to significantly more
than the judicial exceptions (Step 2B: YES). The claim recites patent eligible subject matter.
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that the claim recites
exceptions including the Arrhenius equation, which is a law of nature or abstract idea.
However, the claim is eligible because it recites additional limitations that when considered
as an ordered combination provide meaningful limits on the use of the equation and
improve the technical field of precision rubber molding.
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July 2015 Update Appendix 1: Examples
The invention is an internal combustion engine that solves this problem by automatically
modifying the amount of EGR based upon current engine operations. In particular, the
inventor has discovered that engine performance can be optimized by turning off the EGR
during acceleration, which permits the engine to operate at maximum power output while
retaining the reduction in nitrogen oxides. Therefore, the invention uses a control system
to control the opening and closing of an exhaust gas recirculation valve based upon a rate
of change of the engine throttle, in order to modify the amount of EGR.
Claim
1. An internal combustion engine providing exhaust gas recirculation comprising:
an air intake manifold;
an exhaust manifold;
a combustion chamber to receive air from the air intake manifold, combust a
combination of the received air and fuel to turn a drive shaft, and output resulting exhaust
gas to the exhaust manifold;
a throttle position sensor to detect the position of an engine throttle;
an exhaust gas recirculation valve to regulate the flow of exhaust gas from the
exhaust manifold to the air intake manifold; and
a control system, comprising a processor and memory, to receive the engine throttle
position from the throttle position sensor, calculate a position of the exhaust gas
recirculation valve based upon the rate of change of the engine throttle position and change
the position of the exhaust gas recirculation valve to the calculated position.
Analysis
Claim 1: Eligible.
The claim recites an internal combustion engine with an intake manifold, exhaust manifold,
combustion chamber, throttle position sensor, exhaust gas recirculation valve and a control
system comprising a processor and memory. Thus, the claim is directed to a machine (a
combination of mechanical parts), which is one of the statutory categories of invention
(Step 1: YES).
Next, the claim must be evaluated to determine if the claim is directed to a law of nature,
natural phenomenon or abstract idea. But when the claim is reviewed, it is immediately
evident that although the claim operates by calculating the rate of change, which is a
mathematical relationship describing how a variable changes over a specific period of time,
the claim clearly does not seek to tie up this mathematical relationship so that others
cannot practice it. In particular, the claim’s description of an internal combustion engine
having manifolds, valves, and sensors forming a specific structure that uses the control
system to optimize exhaust gas recirculation makes it clear that the claim as a whole would
clearly amount to significantly more than any recited exception. The claim as a whole adds
meaningful limitations to the use of the mathematical relationship. Additionally, use of the
mathematical relationship improves engine technology. Thus, eligibility of the claim is self‐
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July 2015 Update Appendix 1: Examples
evident, and there is no need to perform the full eligibility analysis (e.g., Steps 2A and 2B).
The claim is patent eligible.
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance indicating that while the claim may
recite a mathematical relationship, the claim clearly amounts to significantly more than the
rate of change by providing meaningful limitations to the mathematical relationship and
improving engine technology.
Claim
15. A method for loading BIOS into a local computer system which has a system processor
and volatile memory and non‐volatile memory, the method comprising the steps of:
(a) responding to powering up of the local computer system by requesting from a
memory location remote from the local computer system the transfer to and storage in the
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July 2015 Update Appendix 1: Examples
volatile memory of the local computer system of BIOS configured for effective use of the
local computer system,
(b) transferring and storing such BIOS, and
(c) transferring control of the local computer system to such BIOS.
Analysis
Claim 15: Eligible.
The claim recites a series of steps for loading BIOS on a local computer system from a
remote storage location. Thus, the claim is directed to a process, which is one of the
statutory categories of invention (Step 1: YES).
Next, the claim must be evaluated to determine if the claim is directed to a law of nature,
natural phenomenon or abstract idea. But when the claim is reviewed, it is immediately
evident that even if the claim did recite a judicial exception, the claim is not attempting to
tie up any such exception so that others cannot practice it. In particular, the claim’s
description of initializing a local computer system using BIOS code stored at a remote
memory location, by triggering the processor to transfer BIOS code between two memory
locations upon a powering up of the computer and transferring control of the processor
operations to that BIOS code, makes it clear that the claim as a whole would clearly amount
to significantly more than any potential recited exception. Thus, eligibility of the claim is
self‐evident in the streamlined analysis, without needing to perform the full eligibility
analysis (e.g., Steps 2A and 2B). The claim is patent eligible.
It is important to point out as well that there is no apparent exception recited in the claim,
which alone would be sufficient for eligibility. While computers operate on mathematical
theory, that underlying operation should not trigger an eligibility analysis – computers and
computer operations are not automatically subjected to an eligibility analysis. The cases in
which courts find mathematical relationships to represent abstract ideas (thus raising
eligibility issues) are those in which the mathematical relationship is recited in the claim as
part of the invention, such as a method of performing a mathematical calculation to obtain
a result. Courts have found computers and computer implemented processes to be
ineligible when generic computer functions are merely used to implement an abstract idea,
such as an idea that could be done by human analog (i.e., by hand or by merely thinking).
If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance, indicating that the claim is not directed
to any judicial exception.
22
Subject Matter Eligibility Examples: Life Sciences
The following examples should be used in conjunction with the 2014 Interim Guidance on Subject
Matter Eligibility (2014 IEG). As the examples are intended to be illustrative only, they should be
interpreted based on the fact patterns set forth below. Other fact patterns may have different
eligibility outcomes. While some of the fact patterns draw from U.S. Supreme Court or U.S. Court of
Appeals for the Federal Circuit decisions, each of the examples shows how claims should be analyzed
under the 2014 IEG. All of the claims are analyzed for eligibility in accordance with their broadest
reasonable interpretation.
Note that the examples herein are numbered consecutively beginning with number 28, because 27
examples were previously issued. A comprehensive index of all examples for use with the 2014 IEG
is provided in the attached appendix (which is an updated version of Appendix 2 to the July 2015
Update).
28. Vaccines
This example illustrates the application of the markedly different characteristics and significantly more
analyses to claims reciting hypothetical nature-based products. It also illustrates the importance of
applying the broadest reasonable interpretation in the eligibility analysis, and how that interpretation
assists in the identification of appropriate naturally occurring counterparts of claimed nature-based
products. Hypothetical claims 1, 2 and 4-6 are eligible in Step 2A, because the claimed nature-based
products have markedly different characteristics from what exists in nature. Hypothetical claim 3 is
ineligible, because the claimed nature-based product lacks markedly different characteristics from what
exists in nature, and the claim fails to amount to significantly more than the exceptions. Hypothetical
claim 7 is eligible in Step 2B, because although the claim is directed to an exception, it recites a
particular and unconventional device that amounts to significantly more than the exception.
Background
Applicant discloses an influenza A viral strain, which was named the “Pigeon flu” because it was
discovered in pigeons. Applicant filed an application disclosing several types of Pigeon flu vaccines,
and evaluating their functional characteristics (such as immunogenicity) in terms of their
seroprotection rate, i.e., the percentage of vaccinated patients who developed immunity to the Pigeon
flu. The disclosed vaccines include:
• Vaccines comprising “live attenuated Pigeon flu virus”, which the specification defines as a
live mutant virus that has been attenuated so that it has at least one mutation (i.e., a change
in the nucleotide sequence) of its polymerase gene, which reduces its virulence as compared
to naturally occurring Pigeon flu virus. No mutations of this polymerase gene are known to
occur in nature. Applicant created this mutant attenuated virus by isolating Pigeon flu virus
from infected pigeons, and passaging the isolated virus through a cell culture at least 50 times
until the desired mutation occurred. The live attenuated Pigeon flu virus is safe (unable to
cause disease in pigeons or other test animals) and strongly immunogenic, e.g., it has a high
seroprotection rate of about 85%.
• Vaccines comprising “inactivated Pigeon flu virus”, which the specification defines as a dead
virus that is formalin-inactivated, i.e., the naturally occurring Pigeon flu virus was contacted
with a chemical solution called formalin that causes structural changes to the virus (e.g., it
chemically modifies the viral nucleic acids in a manner that does not occur in nature) so that
it can no longer reproduce. Because the inactivated virus can no longer replicate, it is unable
to cause disease in pigeons or other test animals, but it is still strongly immunogenic, e.g., it
has a high seroprotection rate of about 75%.
1 May 2016
Subject Matter Eligibility Examples: Life Sciences
• Vaccines comprising Peptide F (a naturally occurring peptide isolated from the Pigeon flu
virus) either alone or mixed with a pharmaceutically acceptable carrier such as water. Prior
to applicant’s invention, and at the time of filing the application, water was routinely and
conventionally used as a carrier for peptide vaccines. Isolation does not change any structural
or functional characteristics of Peptide F. Applicant discloses vaccines where the suitable
pharmaceutically acceptable carrier is selected from a group consisting of a cream, emulsion,
gel, liposome, nanoparticle, or ointment. Applicant discloses that although the carriers in this
group comprise naturally occurring components (such as water and oil), when the
components are assembled into the carrier form, the carrier has changed structural and
physical characteristics that distinguish it from the closest counterpart in nature. E.g., a
pharmaceutically acceptable cream comprising water and vegetable oil has a form (a semi-
solid homogeneous emulsion) that is structurally and physically distinct from the water and
oil in nature. These vaccines are weakly immunogenic, e.g., they have a low seroprotection
rate of about 30%, meaning that many people who are vaccinated with these vaccines will
not develop immunity to the Pigeon flu.
• Vaccines comprising Peptide F mixed with aluminum salt adjuvants (a well-known class of
adjuvants) such as aluminum phosphate (AlPO4). While many of these adjuvants including
aluminum phosphate are naturally occurring, none of them occur together with Peptide F in
nature. Adjuvants are commonly added to vaccines in order to improve their functional
characteristics, e.g., by increasing the strength of the immune response that the vaccines
produce (immunogenicity). The amount of adjuvant sufficient to increase a vaccine’s
immunogenicity to a level high enough to effectively vaccinate a typical patient is called the
“immuno-effective amount”, and those skilled in the art understand that this amount may
vary depending on the particular adjuvant and formulation selected. Adjuvants can increase
immunogenicity in several ways, such as by slowing the release of Peptide F to tissue around
the injection site, and/or by improving the delivery of Peptide F to the patient’s lymph nodes.
On their own or combined with water or other common carriers, Peptide F induces only a
weak protective immune response to Pigeon flu virus (seroprotection rate of 30%), and the
adjuvants do not induce any protective immune response to Pigeon flu virus (seroprotection
rate of 0%). When immuno-effective amounts of the disclosed adjuvants are combined with
Peptide F, however, the combined vaccine induces a strong immune response to Pigeon flu
virus (seroprotection rate of 80%).
Applicant also discloses vaccine delivery devices comprising coated microneedle arrays for delivery
of a vaccine comprising Peptide F. Prior to applicant’s invention, and at the time the application was
filed, it was routine and conventional in the field to use syringes, but not coated microneedle arrays,
for vaccine delivery. A pre-filled syringe is a tube that has been loaded with a vaccine dose prior to
distribution of the vaccine to health professionals. The syringe can be fitted with a hollow needle
about 5/8” to 1.5” long to administer the vaccine subcutaneously or intramuscularly. A coated
microneedle array comprises a plurality of very small solid needles (e.g., less than 0.05” long) that
are coated with a vaccine formulation, which is placed against a patient’s skin to administer the
vaccine into the skin (transcutaneously). Because the microneedles are very small, administration of
a vaccine with a microneedle array is virtually painless.
Claims
1. A vaccine comprising live attenuated Pigeon flu virus.
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Subject Matter Eligibility Examples: Life Sciences
3. A vaccine comprising:
Peptide F; and
a pharmaceutically acceptable carrier.
4. A vaccine comprising:
Peptide F; and
a pharmaceutically acceptable carrier selected from the group consisting of a cream,
emulsion, gel, liposome, nanoparticle, or ointment.
5. A vaccine comprising:
Peptide F; and
an immuno-effective amount of an aluminum salt adjuvant.
6. A vaccine comprising:
Peptide F;
an immuno-effective amount of an aluminum salt adjuvant; and
a pharmaceutically acceptable carrier.
7. A vaccine delivery device comprising a microneedle array that is coated with a vaccine
comprising Peptide F.
Analysis
Claim 1: Eligible.
The claim recites a vaccine comprising live attenuated Pigeon flu virus. Based on the plain meaning
of “vaccine”, and the specification’s definition of “live attenuated Pigeon flu virus”, the broadest
reasonable interpretation of the claim is live mutant Pigeon flu virus that has been attenuated so that
it has at least one mutation (i.e., a change in its nucleotide sequence) that reduces its virulence as
compared to naturally occurring Pigeon flu virus, in an amount sufficient to produce an immunogenic
response in a typical patient. Because viruses are composed of matter, the claim is directed to a
statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The recited
live attenuated virus is a nature-based product that must be compared to its naturally occurring
counterpart to determine if it has markedly different characteristics than the counterpart. Here, the
closest natural counterpart is the naturally occurring Pigeon flu virus from which the live attenuated
virus was mutated. When the live attenuated virus is compared to this counterpart, the comparison
indicates that the live attenuated virus has a different structural characteristic (the nucleotide
sequence of its polymerase gene was changed due to the mutation), which has resulted in the live
attenuated virus having a different functional characteristic (reduced virulence). No mutations of this
gene are known to occur in nature. Thus, under the holding in Myriad, this structural difference is a
markedly different characteristic, because it causes the claimed virus to have a nucleotide sequence
that is different from anything found in nature. Association for Molecular Pathology v. Myriad
Genetics, Inc., 133 S. Ct. 2107, 2119 (2013). While in other fact patterns, a functional change may be
enough by itself to confer eligibility, for this claim the functional change is a result of the structural
change and thus is inseparable from it. Because the live attenuated virus has markedly different
characteristics from what exists in nature, it is not a “product of nature” exception. Thus, the claim is
not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.
Thus, the examiner would not need to evaluate the significantly more considerations for this claim.
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Subject Matter Eligibility Examples: Life Sciences
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Claim 2: Eligible.
The claim recites a vaccine comprising inactivated Pigeon flu virus. Based on the plain meaning of
“vaccine”, and the specification’s definition of “inactivated Pigeon flu virus”, the broadest reasonable
interpretation of the claim is dead Pigeon flu virus that has been structurally altered by contacting it
with formalin so that its nucleic acids are chemically modified in a manner that does not occur in
nature and it can no longer reproduce, in an amount sufficient to produce an immunogenic response
in a typical patient. Because viruses are composed of matter, the claim is directed to a statutory
category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The recited
inactivated virus is a nature-based product that must be compared to its naturally occurring
counterpart to determine if it has markedly different characteristics than the counterpart. Here, the
closest natural counterpart is the naturally occurring Pigeon flu virus. When the inactivated virus is
compared to this counterpart, the comparison indicates that the inactivated virus has a different
structural characteristic (its exposure to formalin has chemically modified its nucleic acids in a
manner that does not occur in nature), which has resulted in the inactivated virus having different
functional characteristics (inability to replicate or cause disease). Like the Chakrabarty bacterium,
which had markedly different characteristics “due to the additional plasmids and resultant ‘capacity
for degrading oil,’” Myriad, 133 S. Ct. at 2117, the inactivated virus has markedly different
characteristics, due to the non-natural chemical modification of its nucleic acids and the resultant
change in the virus’s ability to replicate or cause disease. While in other fact patterns, a functional
change may be enough by itself to confer eligibility, for this claim the functional change is a result of
the structural change and thus is inseparable from it. Because the inactivated virus has markedly
different characteristics from what exists in nature, it is not a “product of nature” exception. Thus,
the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.
Thus, the examiner would not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Claim 3: Ineligible.
The claim recites a vaccine comprising Peptide F and a pharmaceutically acceptable carrier. Based
on the plain meaning of “vaccine” and “pharmaceutically acceptable carrier”, the broadest reasonable
interpretation (BRI) of the claim is a sufficient amount of Peptide F to produce an immunogenic
response in a typical patient, which is mixed with a pharmaceutically sufficient amount of a carrier
such as water. Thus, one embodiment within the BRI is a mixture of Peptide F and water. Because the
peptide and carrier are composed of matter, the claim is directed to a statutory category, e.g., a
composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The recited
mixture of Peptide F and water is a nature-based product that must be compared to its closest
naturally occurring counterpart to determine if it has markedly different characteristics than the
counterpart. Because Peptide F and water do not occur together in nature, there is no naturally
occurring counterpart mixture for comparison, and so the claimed mixture is compared to its
naturally occurring components, i.e., Peptide F, and water. Peptide F is naturally occurring, and water
4 May 2016
Subject Matter Eligibility Examples: Life Sciences
is naturally occurring, so neither would be eligible as claimed on their own. While the mixture of
these two naturally occurring components is novel and does not occur in nature, there is no
indication that mixing these components changes the structure, function, or other properties of the
peptide or water. For example, the claim encompasses a mixture where the peptide is
heterogeneously dispersed in the water, but such heterogeneous mixing does not change the
structure, function, or other properties of the peptide or the water in any marked way. Instead, the
peptide retains its naturally occurring structure and function, and is merely dispersed in the water,
which also retains its naturally occurring structure and function. Thus, for at least one embodiment
within the broadest reasonable interpretation, the claimed mixture as a whole does not display
markedly different characteristics compared to the naturally occurring counterparts. Accordingly,
each component (the peptide and the carrier) is a “product of nature” exception, and the claim is
directed to at least one exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions.
Because the component elements (the peptide and carrier “product of nature” exceptions) do not
occur together in nature and are not markedly changed by their combination into a mixture, each is
considered as an additional element to the other. This consideration provides an opportunity to
explore whether this combination of “products of nature” amounts to significantly more than the
products themselves. As discussed above, mixing the peptide with a carrier such as water does not
markedly change the characteristics of either component, because each component continues to have
the same properties in the mixture as it had alone. In addition, using a carrier in a peptide vaccine
was well-understood, routine & conventional prior to applicant’s invention and at the time of filing
the application, so the mixing of the peptide and carrier, when recited at this high level of generality,
does not meaningfully limit the claim. Thus, the claim as a whole does not amount to significantly
more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible
subject matter.
A rejection of claim 3 should identify the exceptions by pointing to the nature-based products in the
claim (the peptide and carrier) and explaining why they lack markedly different characteristics from
their naturally occurring counterparts, e.g., because there are no changes in structure, function, or
other characteristics. The rejection should also explain that combining the peptide and carrier does
not amount to significantly more than the exceptions, because their combination is well-understood,
routine and conventional in the field.
If the examiner believes that it would be helpful to cite an analogous court decision, the rejection
could include an explanation of how the claimed mixture is like the novel bacterial mixture of Funk
Brothers, which was held ineligible because each species of bacteria in the mixture (like each
component in the peptide-carrier mixture) continued to have “the same effect it always had”, i.e., it
lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,
131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of
Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any
way”).
Claim 4: Eligible.
The claim recites a vaccine comprising Peptide F in a pharmaceutically acceptable carrier selected
from the group consisting of a cream, emulsion, gel, liposome, nanoparticle, or ointment. Based on
the plain meaning of “vaccine” and “pharmaceutically acceptable carrier”, the broadest reasonable
interpretation (BRI) of the claim is a sufficient amount of Peptide F to produce an immunogenic
response in a typical patient, which is mixed with a sufficient amount of other substances to produce
a carrier form suitable for administration to a patient. The BRI thus encompasses, for example, a
5 May 2016
Subject Matter Eligibility Examples: Life Sciences
vaccine comprising Peptide F in a carrier that is a cream. Because the plain meaning of a “cream” in
the pharmaceutical arts is a semi-solid homogeneous emulsion comprising water and oil, the
recitation of a cream necessarily requires (i) the presence of water and an oil (such as naturally
occurring cottonseed oil) in addition to Peptide F, and (ii) that the water and oil be structurally
arranged into a homogenous emulsion to produce a semi-solid form. Thus, one embodiment within
the BRI is an emulsion comprising Peptide F mixed with small uniform droplets of cottonseed oil that
are homogenously dispersed in water. Because the peptide and the carrier are composed of matter,
the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
cream containing Peptide F, cottonseed oil, and water is a nature-based product that must be
compared to its closest naturally occurring counterpart to determine if it has markedly different
characteristics than the counterpart. Here, all three substances (the peptide, cottonseed oil, and
water) do not occur together in nature, so there is no naturally occurring counterpart mixture for
comparison. The mixture is therefore compared to its naturally occurring components, i.e., Peptide
F, cottonseed oil, and water. The claimed cream has different structural and physical characteristics
than its naturally occurring components, for example the oil droplets are small, uniform in size, and
homogenously dispersed in the water, which causes the resultant cream to have a semi-solid and
non-flowable form at room temperature as compared to the oil and water, which are both flowable
liquids at room temperature in nature. Because the oil and water are emulsified, the cream will also
adhere to a patient’s skin or mucous membranes much longer than oil or water in their natural non-
emulsified form, thus permitting a sufficient amount of peptide to transfer from the cream into the
patient’s tissues where it will then stimulate an immune response. In contrast, the oil or water, if used
in their natural state, would simply slide off the patient’s skin after a short time. The cream’s changed
form and adherence are marked differences in structural and physical characteristics as compared
to the natural counterparts, and therefore the cream is not a “product of nature” exception. Thus, the
claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.
Thus, the examiner would not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Practice Note: The BRI of claim 4 also encompasses cream embodiments in which the oil is a non-
naturally occurring oil, or is a naturally occurring oil other than cottonseed oil, or in which the
homogenous emulsion is a water-in-oil emulsion instead of an oil-in-water emulsion, as well as
embodiments in which the carrier is something other than a cream, e.g., a liposome or nanoparticle
carrier. If the examiner were to analyze such embodiments for markedly different characteristics, the
analysis may differ slightly due to the choice of different counterparts, but the same result of
eligibility would be achieved because in every embodiment, the plain meaning of each carrier recited
in the claim requires that the carrier have structural and physical characteristics that distinguish it
from the closest counterpart in nature.
Claim 5: Eligible.
The claim recites a vaccine comprising Peptide F and an immuno-effective amount of an aluminum
salt adjuvant. Based on the plain meaning of “vaccine” and “immuno-effective amount”, the broadest
reasonable interpretation (BRI) of the claim is a mixture of (i) a sufficient amount of Peptide F to
produce an immunogenic response in a typical patient, and (ii) a sufficient amount of an aluminum
salt adjuvant (e.g., aluminum phosphate; AlPO4) to increase the vaccine’s immunogenicity (measured
here by seroprotection rate) to a level high enough to effectively vaccinate a typical patient. Thus,
6 May 2016
Subject Matter Eligibility Examples: Life Sciences
one embodiment within the BRI is a mixture of Peptide F with a sufficient amount of aluminum
phosphate to increase the vaccine’s immunogenicity. Because the peptide and adjuvant are
composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step
1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
mixture of Peptide F and aluminum phosphate is a nature-based product that must be compared to
its closest naturally occurring counterpart to determine if it has markedly different characteristics
than the counterpart. Because Peptide F and aluminum phosphate do not occur together in nature,
there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is
compared to its naturally occurring components, i.e., Peptide F, and the adjuvant (e.g., aluminum
phosphate). There is no indication that mixing these components changes the structure of the peptide
or aluminum phosphate. However, the mixture has a changed functional property, in that the
immunogenicity of the mixture is different (higher) than the mere “sum” of the immunogenicity of
the individual components. In other words, the peptide by itself has poor immunogenicity (30%
seroprotection rate) and the adjuvant by itself has no immunogenicity (0% seroprotection rate) with
respect to Pigeon flu virus, but when combined, the resultant mixture has a greatly enhanced
immunogenicity (80% seroprotection rate) with respect to Pigeon flu virus. The mixture’s changed
immunogenicity is a marked difference in functional characteristics as compared to the natural
counterparts, and therefore the mixture is not a “product of nature” exception. Thus, the claim is not
directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.
Thus, the examiner would not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Practice Note: The BRI of claim 5 also encompasses embodiments in which the adjuvant is a non-
naturally occurring aluminum salt, or is a naturally occurring aluminum salt other than aluminum
phosphate. If the examiner were to analyze such an embodiment for markedly different
characteristics, the analysis may differ slightly due to the choice of different counterparts, but the
same result of eligibility would be achieved because in every embodiment, the immuno-effective
amount of the adjuvant will result in the claimed mixture exhibiting the same marked difference in
immunogenicity described in the preceding analysis.
Claim 6: Eligible.
The claim recites a vaccine comprising Peptide F, an immuno-effective amount of an aluminum salt
adjuvant, and a pharmaceutically acceptable carrier. Based on the plain meaning of “vaccine”,
“immuno-effective amount”, and “pharmaceutically acceptable carrier”, the broadest reasonable
interpretation of the claim is a mixture of (i) a sufficient amount of Peptide F to produce an
immunogenic response in a typical patient, (ii) a sufficient amount of an aluminum salt adjuvant (e.g.,
aluminum phosphate; AlPO4) to increase the vaccine’s immunogenicity (measured here by
seroprotection rate) to a level high enough to effectively vaccinate a typical patient, and (iii) a
pharmaceutically sufficient amount of a carrier such as water. Thus, one embodiment within the BRI
is a mixture of Peptide F, a sufficient amount of aluminum phosphate to increase the vaccine’s
immunogenicity, and water. Because the peptide, adjuvant, and carrier are composed of matter, the
claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
mixture of Peptide F, aluminum phosphate, and water is a nature-based product that must be
7 May 2016
Subject Matter Eligibility Examples: Life Sciences
compared to its closest naturally occurring counterpart to determine if it has markedly different
characteristics than the counterpart. Here, all three substances (the peptide, aluminum phosphate,
and water) do not occur together in nature, so there is no naturally occurring counterpart mixture
for comparison. However, aluminum phosphate does occur naturally in combination with water (e.g.,
in soil). Accordingly, the closest naturally occurring counterparts to which the claimed mixture is
compared are Peptide F, and the naturally occurring water/aluminum phosphate combination. There
is no indication that mixing the peptide with the water/aluminum phosphate combination changes
the structure of either component, but the mixture does have a changed functional property, in that
the immunogenicity of the mixture is different (higher) than the mere “sum” of the immunogenicity
of the individual components. In other words, the peptide by itself has poor immunogenicity (30%
seroprotection rate), and the water/aluminum phosphate combination by itself has no
immunogenicity (0% seroprotection rate) with respect to Pigeon flu virus, but when combined, the
resultant mixture has a greatly enhanced immunogenicity (80% seroprotection rate) with respect to
Pigeon flu virus. The mixture’s changed immunogenicity is a marked difference in functional
characteristics as compared to the natural counterparts, and therefore the mixture is not a “product
of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as
eligible subject matter.
Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.
Thus, the examiner would not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Practice Note: The BRI of claim 6 also encompasses embodiments in which the adjuvant is a non-
naturally occurring aluminum salt, or is a naturally occurring aluminum salt other than aluminum
phosphate, and embodiments in which the carrier is something other than water. If the examiner
were to analyze such an embodiment for markedly different characteristics, the analysis may differ
slightly due to the choice of different counterparts, but the same result of eligibility would be
achieved because in every embodiment, the immuno-effective amount of the adjuvant will result in
the claimed mixture exhibiting the same marked difference in immunogenicity described in the
preceding analysis.
Claim 7: Eligible.
The claim recites a vaccine delivery device comprising a microneedle array that is coated with a
vaccine comprising Peptide F. Based on the plain meaning of “microneedle array” and “vaccine”, the
broadest reasonable interpretation (BRI) of the claim is an array of small solid needles coated with a
sufficient amount of Peptide F to produce an immunogenic response in a typical patient. Thus, one
embodiment within the BRI is an array of small solid needles (the microneedle array) coated with
Peptide F. The microneedle array is a manufacture and the peptide is composed of matter; thus, the
claim is directed to at least one statutory category, e.g., a manufacture and/or a composition of matter
(Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The
microneedle array is not a nature-based product, but the Peptide F is a nature-based product that
must be compared to its closest naturally occurring counterpart (naturally occurring Peptide F) to
determine if it has markedly different characteristics than the counterpart in its natural state as part
of the virus. There is no indication in the specification that isolation changes any structural or
functional characteristics of Peptide F, or that coating the needles in the array with Peptide F results
in the peptide having any characteristics (structural, functional, or otherwise) that are different from
the naturally occurring peptide in its natural state. Thus, the claimed peptide does not display
8 May 2016
Subject Matter Eligibility Examples: Life Sciences
markedly different characteristics compared to the naturally occurring counterpart. Accordingly, the
peptide is a “product of nature” exception, and the claim is directed to at least one exception (Step
2A: YES).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
Besides the exception, the claim recites an additional element of the microneedle array, which is
coated with the peptide. Prior to applicant’s invention, and at the time the application was filed,
coated microneedle arrays were known to most scientists in the field, but were not routinely or
conventionally used to administer vaccines. The conventional delivery device was a syringe that was
routinely pre-filled with the vaccine. Thus, the claim’s recitation of a microneedle array coated with
the peptide is an application of the exception with a particular manufacture that is not a conventional
delivery device, and thus is more than a mere instruction to “apply” the peptide (the exception) using
a well-understood, routine or conventional device in the field. It is an unconventional limitation that
confines the exception to a particular useful application of the exception. Thus, the recitation of the
coated microneedle array yields a claim as a whole that amounts to significantly more than the
“product of nature” exception itself (Step 2B: YES). The claim is eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the peptide is a “product of nature” exception
because it lacks markedly different characteristics from its naturally occurring counterpart, e.g.,
because there are no changes in structure, function, or other characteristics. However, the claim is
eligible because it recites a particular, unconventional limitation (the coated microneedle array) that
confines the exception to a particular useful application, and that is more than a mere instruction to
“apply” the exception using a well-understood, routine or conventional device in the field.
Background
“Julitis” is an autoimmune disease affecting more than 17 million people in North America, which
develops when the immune system mistakes normal skin cells for pathogens. Julitis causes chronic
inflammation of the skin that results in an itchy and extremely painful rash on the face, hands, and
feet. Conventionally, julitis is diagnosed by a physical examination of the characteristic rash.
However, because the rash caused by julitis looks similar to rashes caused by rosacea, doctors often
misdiagnosed people as having rosacea when they actually had julitis.
Applicant has discovered that the presence of a protein known as “JUL-1” in a person’s body is
indicative that the person has julitis. All julitis patients have JUL-1 in their plasma, skin, hair and nails,
but this protein is not found in persons who do not have julitis (e.g., patients with rosacea). Applicant
discloses detecting JUL-1 by routine and conventional methods such as (i) physical biopsies of skin,
hair or nails, or (ii) immunoassays in which a sample from a patient (e.g., a plasma or skin sample) is
contacted with an antibody to the protein being detected, and then binding between the antibody
and the protein is detected using a laboratory technique such as fluoroscopy. In particular, applicant
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Subject Matter Eligibility Examples: Life Sciences
discloses detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human
anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a
porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody
named “mAb-D33” that was created by applicant). Prior to applicant’s invention, and at the time the
application was filed, the use of porcine antibodies in veterinary therapeutics was known to most
scientists in the field, but these antibodies were not routinely or conventionally used to detect human
proteins such as JUL-1.
Prior to applicant’s invention, and at the time the application was filed, julitis was conventionally
treated with anti-tumor necrosis factor (TNF) antibodies, but for unknown reasons, some patients
do not respond well to this conventional treatment. Because rosacea treatments (e.g., antibiotics) are
not effective against julitis, julitis patients who were misdiagnosed as having rosacea also did not
respond well to the treatments they were given. Some anti-TNF antibodies are naturally occurring in
patients with other autoimmune diseases such as lupus. Applicant has successfully treated julitis
patients (even those who are non-responsive to anti-TNF antibodies) with topical vitamin D. Prior to
applicant’s invention, and at the time the application was filed, vitamin D was commonly used as an
oral supplement to maintain bone health (e.g., in fortified dairy products), but doctors were not
commonly or routinely administering topical vitamin D to patients with julitis or other diseases.
Claims
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample
with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
10 May 2016
Subject Matter Eligibility Examples: Life Sciences
7. A method of treating a patient with julitis, the method comprising administering an effective
amount of anti-TNF antibodies to a patient suffering from julitis.
Analysis
Claim 1: Eligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claim
recites steps of obtaining a plasma sample from a patient (step a) and detecting whether JUL-1 is
present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and
detecting resultant binding between JUL-1 and the antibody (step b). These steps do not recite or
describe any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S.
__, 132 S. Ct. 1289, 1297 (2012) (recited steps of administering a drug to a patient and determining
the resultant level of 6-thioguanine in the patient “are not themselves natural laws”). Accordingly,
the claim is not directed to an exception (Step 2A: NO), and is eligible.
Note that although nature-based product limitations are recited in the claim (e.g., the plasma sample
and JUL-1), analysis of the claim as a whole indicates that the claim is focused on a process of
detecting whether JUL-1 is present in a plasma sample, and is not focused on the products per se.
Thus, there is no need to perform the markedly different characteristics analysis on the recited
nature-based product limitations. In addition, note that because the analysis of this claim ends with
eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would
not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
Claim 2: Ineligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. In step c, the
claim recites diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is
detected, which describes a correlation or relationship between the presence of JUL-1 in a patient’s
11 May 2016
Subject Matter Eligibility Examples: Life Sciences
plasma and the presence of julitis in the patient. This limitation sets forth a judicial exception, because
this type of correlation is a consequence of natural processes, similar to the naturally occurring
correlation found to be a law of nature by the Supreme Court in Mayo). Additionally, step c could be
performed by a human using mental steps or basic critical thinking, which are types of activities that
have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry
Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about
the results in Grams). Thus, the claim is directed to at least one exception (Step 2A: YES), which may
be termed a law of nature, an abstract idea, or both. Note that although the claim recites several
nature-based product limitations (e.g., the plasma sample and JUL-1), the claim as a whole is focused
on a process of detecting whether JUL-1 is present in a plasma sample, and is not focused on the
products per se. Thus, there is no need to perform the markedly different characteristics analysis on
the recited nature-based product limitations.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the
law of nature, the claim recites additional steps of obtaining a plasma sample from a human patient
(step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma
sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody
(step b). Obtaining a sample in order to perform tests is well-understood, routine and conventional
activity for those in the field of diagnostics. Further, the step is recited at a high level of generality
such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary
to use the correlation. Detecting whether JUL-1 is present in the plasma sample merely instructs a
scientist to use any detection technique with any generic anti-JUL-1 antibody. When recited at this
high level of generality, there is no meaningful limitation, such as a particular or unconventional
machine or a transformation of a particular article, in this step that distinguishes it from well-
understood, routine, and conventional data gathering activity engaged in by scientists prior to
applicant’s invention, and at the time the application was filed, e.g., the routine and conventional
techniques of detecting a protein using an antibody to that protein. Further, it is well established that
the mere physical or tangible nature of additional elements such as the obtaining and detecting steps
does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp.
v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations
to the exception not already present when the elements are considered separately. Unlike the eligible
claim in Diehr in which the elements limiting the exception are individually conventional, but taken
together act in concert to improve a technical field, the claim here does not invoke any of the
considerations that courts have identified as providing significantly more than an exception. Even
when viewed as a combination, the additional elements fail to transform the exception into a patent-
eligible application of that exception. Thus, the claim as a whole does not amount to significantly
more than the exception itself (Step 2B: NO). The claim is not eligible.
A rejection of claim 2 should identify step c as an exception by pointing to it in the claim and
explaining why it is an exception, e.g., that the recited correlation is a law of nature because it is a
consequence of a natural process in the body, and/or that the critical thinking step is an abstract idea
similar to those found by the courts to be an exception. The rejection should also identify the
additional elements in the claim and explain why they do not amount to significantly more, in this
case, because they merely add data gathering and well-understood, routine and conventional
activities that do not impose meaningful limits on the law of nature.
12 May 2016
Subject Matter Eligibility Examples: Life Sciences
Claim 3: Eligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES). Because claim 3 recites the same correlation and critical thinking step (step c) as claim
2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a
judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations
(the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different
characteristics analysis on them, for the reasons discussed above for claim 2.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the
exception, the claim recites additional steps of obtaining a plasma sample from a human patient (step
a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample
with a porcine anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody
(step b). The additional element of obtaining a plasma sample (step a) does not by itself add
significantly more, for the reasons discussed above for claim 2. Step b, however, also requires
detecting using a porcine anti-JUL-1 antibody. Prior to applicant’s invention, and at the time the
application was filed, the use of porcine antibodies in veterinary therapeutics was known to most
scientists in the field. But significantly, there is no evidence that porcine antibodies were routinely or
conventionally used to detect human proteins such as JUL-1. Thus, the claim’s recitation of detecting
JUL-1 using a porcine antibody is an unconventional step that is more than a mere instruction to
“apply” the correlation and critical thinking step (the exception) using well-understood, routine or
conventional techniques in the field. Whether taken alone or as a combination with the other
additional elements, the recitation of detecting JUL-1 using a porcine anti-JUL-1 antibody yields a
claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim
is eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the correlation and critical thinking step
(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites
additional limitations that when considered as a combination are unconventional steps that are more
than a mere instruction to “apply” the exception using well-understood, routine or conventional
techniques in the field.
Claim 4: Eligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES). Because claim 4 recites the same correlation and critical thinking step (step c) as claim
2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a
judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations
(the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different
characteristics analysis on them, for the reasons discussed above for claim 2.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the
exception, the claim recites the additional elements of obtaining a plasma sample from a human
patient (step a) and detecting the presence of JUL-1 in the sample by contacting the plasma sample
with antibody mAb-D33 and detecting resultant binding between the antibody and JUL-1 (step b).
The additional element of obtaining a plasma sample (step a) does not add significantly more by itself,
for the reasons discussed above for claim 2. Step b, however, requires detecting using a specific anti-
13 May 2016
Subject Matter Eligibility Examples: Life Sciences
JUL-1 antibody (mAb-D33). Prior to applicant’s invention, and at the time the application was filed,
antibody mAb-D33 was not routinely or conventionally used to detect human proteins such as JUL-
1. Thus, the claim’s recitation of detecting JUL-1 using mAb-D33 is an unconventional step that is
more than a mere instruction to “apply” the correlation and critical thinking step (the exception)
using well-understood, routine or conventional techniques in the field. Whether taken alone or as a
combination with the other additional elements, the recitation of detecting JUL-1 using mAb-D33
yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES).
The claim is eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the correlation and critical thinking step
(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites
additional limitations that when considered as a combination are unconventional steps that are more
than a mere instruction to “apply” the exception using well-understood, routine or conventional
techniques in the field.
Claim 5: Eligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES). Because claim 5 recites the same correlation and critical thinking step (step c) as claim
2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a
judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations
(the plasma sample, JUL-1, and vitamin D), there is no need to perform the markedly different
characteristics analysis on them, for the reasons discussed above for claim 2.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the
exception, the claim recites the additional elements of obtaining a plasma sample from a human
patient (step a) and detecting the presence of JUL-1 in the sample (step b). When considered
individually, steps a and b by themselves do not add significantly more to the exception for the
reasons discussed above for claim 2 (e.g., step b in this claim is recited at an even higher level of
generality than in claim 2, that encompasses any protein detection method, whether or not it uses
antibodies). However, this claim further recites an additional element of administering an effective
amount of topical vitamin D to the diagnosed patient (step d). Vitamin D was known to doctors, and
was routinely and conventionally used as an oral supplement to maintain bone health prior to
applicant’s invention, and at the time the application was filed. However, mere knowledge of vitamin
D or its use in other ways to treat other medical conditions does not make the administration of
topical vitamin D to treat julitis a conventional step that those in this field would routinely practice.
The evaluation turns on whether the use of topical vitamin D was widely prevalent in the field at the
time the invention was made and the application was filed. Because it was not, the recitation of
administering topical vitamin D is an unconventional step that is more than a mere instruction to
“apply” the correlation and critical thinking step (the exception) using well-understood, routine or
conventional techniques in the field. Whether taken alone or as a combination with the other
additional elements, the recitation of administering topical vitamin D yields a claim as a whole that
amounts to significantly more than the exception itself (Step 2B: YES). The claim is thus eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the correlation and critical thinking step
(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites
additional limitations that when considered as a combination are unconventional steps that are more
14 May 2016
Subject Matter Eligibility Examples: Life Sciences
than a mere instruction to “apply” the exception using well-understood, routine or conventional
techniques in the field.
Claim 6: Eligible.
The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma
sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention
(Step 1: YES). Because claim 6 recites the same correlation and critical thinking step (step c) as claim
2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a
judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations
(the plasma sample, JUL-1, and the anti-TNF antibodies), there is no need to perform the markedly
different characteristics analysis on them, for the reasons discussed above for claim 2.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the
exception, the claim recites the same additional elements of obtaining a plasma sample from a human
patient (step a) and detecting the presence of JUL-1 in the sample (step b) as claim 5. When
considered individually, steps a and b do not by themselves add significantly more to the exception
for the reasons discussed above for claims 2 and 5. This claim further recites an additional element
of administering an effective amount of anti-TNF antibodies to the diagnosed patient (step d). Prior
to applicant’s invention, and at the time the application was filed, however, administering these
antibodies to treat a patient diagnosed with julitis was well-understood, routine and conventional
activity engaged in by doctors in the field. Further, it is well established that the mere physical or
tangible nature of additional elements such as the obtaining, detecting, and administering steps does
not automatically confer eligibility on a claim directed to an exception (see, e.g., Alice Corp., 134 S.Ct.
at 2358-59).
When the additional elements are viewed as a combination, however, the additional elements (steps
a, b and d) amount to a claim as a whole that adds meaningful limits on the use of the exception (the
correlation and critical thinking step). The totality of these steps including the recitation of a
particular treatment (administration of an effective amount of anti-TNF antibodies) in step d
integrate the exception into the diagnostic and treatment process, and amount to more than merely
diagnosing a patient with julitis and instructing a doctor to generically “treat it.” Further, the
combination of steps, which is not routine and conventional, ensures that patients who have julitis
will be accurately diagnosed (due to the detection of JUL-1 in their plasma) and properly treated with
anti-TNF antibodies, as opposed to being misdiagnosed as having rosacea as was previously
commonplace. See Diamond v. Diehr, 450 U.S. 175, 188 (1981) (“a new combination of steps in a
process may be patentable even though all the constituents of the combination were well known and
in common use before the combination was made”). Thus, the administration of anti-TNF antibodies,
when considered as a combination with the other additional elements, yields a claim as a whole that
amounts to significantly more than the exception itself (Step 2B: YES). The claim is eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the correlation and critical thinking step
(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites
additional limitations that when considered as a combination are a meaningful way of applying the
exception that is more than a mere instruction to “apply” the exception.
Claim 7: Eligible.
The claim recites at least one step or act, e.g., administering an effective amount of anti-TNF
antibodies to a patient suffering from julitis. Thus, the claim is directed to a process, which is one of
the statutory categories of invention (Step 1: YES).
15 May 2016
Subject Matter Eligibility Examples: Life Sciences
The claim is then analyzed to determine whether it is directed to any judicial exception. Although the
claim recites a nature-based product limitation (the anti-TNF antibodies), analysis of the claim as a
whole indicates that the claim is focused on a process of practically applying the product to treat a
particular disease (julitis), and not on the product per se. Accordingly, it is not necessary to perform
the markedly different characteristics analysis on the antibodies. The recited step of administering
antibodies to a patient suffering from julitis does not recite or describe any recognized exception.
See, e.g., Mayo, 132 S. Ct. at 1297 (recited steps of administering a drug to a patient and determining
the resultant level of 6-thioguanine in the patient “are not themselves natural laws”). Thus, the claim
is not directed to an exception (Step 2A: NO). The claim is eligible.
Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis does
not need to be performed. Thus, the examiner would not need to evaluate the significantly more
considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
16 May 2016
Subject Matter Eligibility Examples: Life Sciences
texiol. Applicant discloses that this neutralization does not involve a chemical reaction. The
same sensory panel tasted mixtures having various concentrations of Compound N and texiol,
and found that a formulation comprising 1-5% texiol, 1-2% Compound N, and the balance
water produced the most palatable results for a dietary sweetener with no bitter aftertaste.
When Compound N is added in the specified amount, the changed taste perception occurs
whether or not the texiol is fully dissolved, e.g., even when large crystals of texiol are used.
• A dietary sweetener solid gel formulation comprising 5% texiol mixed with water and/or
fruit juice and sufficient pectin to provide a solid gel. The Texas mint plant does not contain
pectin in nature. Solid gel formulations are useful commercial sweeteners because their solid,
jelly-like consistency makes them spreadable onto other foods, such as bread, cake layers, or
pastry dough. Solid gels can also be formed into candies such as jellybeans. Applicant
discloses that the same sensory panel tasted the gel formulation and found that it had
improved organoleptic properties (e.g., a more pleasant mouthfeel) and a solid but easily-
spreadable consistency as compared to naturally occurring texiol (either in the sap or
crystallized).
• A dietary sweetener comprising texiol in granular form for use by consumers. Naturally
occurring texiol forms irregular crystals that aggregate into large chunks of varying size and
shape. Due to this variation, sweeteners formed from these irregular crystals do not have
consistent and commercially acceptable dissolution rates. For example, a consumer
attempting to sweeten iced tea with irregular texiol crystals will typically experience a need
to add more than the expected amount of texiol in order to obtain the desired level of
sweetness, because the larger particles of texiol dissolve more slowly (if at all) than the
smaller particles even with vigorous stirring. The presence of these undissolved crystals may
also cause an undesirable gritty mouth feel as the sweetened tea is consumed. To solve the
problem of inconsistent and slow dissolution rates, applicant has produced granulated texiol
formulations having even and regular particle size distributions, e.g., by grinding or milling
coarse texiol crystals into an even and regular powder, or by crystallizing texiol in a
controlled manner that forms regularly sized and shaped crystals. Granular texiol having a
particle size of X10 of 80 microns and X90 of 300 microns is preferred, because this particle
size distribution results in a greatly increased (and consistent) dissolution rate in water-
based liquids as compared to naturally occurring texiol crystals. The terms “X10” and “X90”
refer to the median diameter of the particles, as measured on a volume basis by a laser
diffraction particle sizing system. For “X10”, 10 percent of the particles have a diameter
smaller than the specified size, and 90 percent of the particles have a larger diameter, and for
“X90”, 90 percent of the particles have a diameter smaller than the specified size, and 10
percent of the particles have a larger diameter.
• A dietary sweetener comprising texiol in a controlled release formulation. Applicant discloses
that the same sensory panel, upon tasting naturally occurring texiol, reported perceiving an
immediate burst of sweetness that rapidly dissipated. Applicant discloses formulations that
achieve controlled release (e.g., release of specific amounts of texiol from the formulation at
specific time intervals, or over a prolonged period of time) by mixing the texiol with other
substances such as polymers and/or changing the form of the texiol so that a controlled
perception of sweetness is achieved. For example, in one such formulation, texiol particles
are encapsulated in a polymer-emulsifier mixture that delays release of the texiol as
compared to unencapsulated (e.g., naturally occurring) texiol particles. These controlled
release formulations prolong enjoyment of a texiol-sweetened product such as chewing gum,
by altering the time over which texiol’s sweetness is perceived.
17 May 2016
Subject Matter Eligibility Examples: Life Sciences
Claims
1. A dietary sweetener comprising:
texiol; and
water.
Analysis
Claim 1: Ineligible
The claim recites a dietary sweetener comprising texiol and water. Based on the specification’s
definition of “dietary sweetener”, the broadest reasonable interpretation (BRI) of the claim is a
mixture of texiol and water in any amount that will be understood as a sweetener to those of ordinary
skill in the art. Thus, the BRI covers the naturally occurring sap of the Texas mint plant, which
contains texiol and water. Because texiol and water are composed of matter, the claim is directed to
a statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.
As noted above, the BRI of this claim encompasses the naturally occurring sap. Because the sap is
naturally occurring, it cannot have markedly different characteristics from how it exists in nature,
and therefore the claimed mixture of texiol and water (i.e., the sap) is a “product of nature” exception.
Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, 2116 (2013) (naturally
occurring things are “products of nature” which cannot be patented). Thus, the claim is directed to at
least one exception (Step 2A: YES).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
In this case, the combination as claimed occurs in nature (as sap) so there are no additional elements
to the claimed combination. The claim is to a “product of nature” exception with nothing that adds
significantly more (Step 2B: NO). Claim 1 is not eligible.
A rejection of claim 1 should identify the exception(s) by pointing to the nature-based product in the
claim (the combination of texiol-water) and explaining that it is a “product of nature” exception
18 May 2016
Subject Matter Eligibility Examples: Life Sciences
because it is naturally occurring. The rejection should also explain that because the combination of
the texiol and water is the exception, there are no additional elements in the claim that could amount
to significantly more than the exception.
If the examiner believes that it would be helpful to cite an analogous court decision, the rejection
could include an explanation of how the claimed mixture is like the cloned mammals of Roslin, which
were held ineligible because, as claimed, the cloned mammals lacked markedly different
characteristics from their naturally occurring counterparts. In re Roslin Institute (Edinburgh), 750
F.3d 1333, 1339 (2014).
Claim 2: Ineligible
The claim recites a dietary sweetener comprising 1-5 percent texiol and at least 90 percent water.
Based on the specification’s definition of “dietary sweetener”, the broadest reasonable interpretation
(BRI) of the claim is a mixture of texiol and water in the specified amounts. In this case, the BRI does
not cover the naturally occurring sap of the Texas mint plant, which contains a different amount of
texiol. Because texiol and water are composed of matter, the claim is directed to a statutory category,
e.g., a composition of matter (Step 1: YES).
The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.
The claimed mixture is a nature-based product that is compared to its closest naturally occurring
counterpart, in order to determine if it has markedly different characteristics from this counterpart.
As noted above, the BRI of this claim is limited to the recited percentages and thus does not
encompass the naturally occurring sap of the Texas mint plant. Accordingly, the closest naturally
occurring counterpart is not the sap, but the naturally occurring texiol-water mixture in the sap. By
comparing the claimed mixture and its component parts to the naturally occurring texiol-water
mixture in the sap, all potential changes in characteristics can be investigated.
Texiol is naturally occurring, and water is naturally occurring, so neither would be eligible as claimed
on its own. Although the combination as claimed is novel and does not occur in nature, there is no
indication that mixing them in the recited amounts (i.e., 1-5 percent texiol and at least 90 percent
water) changes the structure, function, or other properties of the texiol or water in any marked way.
Instead, the texiol retains its naturally occurring structure and properties (e.g., its sweetness and
bitter aftertaste), and is merely located in water, which also retains its naturally occurring structure
and properties (e.g., its liquid form at room temperature). These characteristics are also the same as
the naturally occurring texiol and water in the sap, which is also a sweet liquid at room temperature.
Thus, the claimed mixture as a whole does not display markedly different characteristics compared
to the closest naturally occurring counterpart. Accordingly, each component (the texiol and the
water) is a “product of nature” exception, and the claim is directed to at least one exception (Step 2A:
YES).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions.
Because the component elements (the texiol and water “product of nature” exceptions) do not occur
together in nature as claimed (i.e., in the recited amounts) and are not markedly changed by their
combination into a mixture, each component is considered as an additional element to the other to
determine whether their combination results in significantly more than the products of nature. This
consideration of the texiol as an additional element to the water, and vice-versa, provides an
opportunity to explore whether this combination of “products of nature” amounts to significantly
more than the products themselves. As discussed above, mixing the sweetener with water does not
markedly change the characteristics of either component, because each component continues to have
the same properties in the mixture as it had alone. Prior to applicant’s invention and at the time of
19 May 2016
Subject Matter Eligibility Examples: Life Sciences
filing the application, mixing a sweetener with water (or vice-versa) was well-understood, routine
and conventional in the field, as evidenced by, e.g., the ubiquity of simple syrup and stevia-based
liquid sweeteners. The recitation of specific amounts of texiol and water does not affect this analysis,
because it was also well-understood, routine and conventional at the time to mix specific amounts of
sweeteners with water (or vice-versa) and to vary the amounts of the combination, e.g., to achieve
commercially acceptable sweetness levels and provide sweeteners for different purposes. Thus, the
mixing of texiol and water, when recited at this high level of generality, does not meaningfully limit
the claim, and the claim as a whole does not amount to significantly more than each “product of
nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
A rejection of claim 2 should identify the exceptions by pointing to the nature-based product
limitations in the claim (texiol and water) and explaining why they lack markedly different
characteristics from their naturally occurring counterparts, e.g., because there are no marked
changes in structure, function or other characteristics. The rejection also should explain that mixing
texiol and water does not amount to significantly more than the exceptions, because mixtures of
sweeteners and water are well-understood, routine and conventional in the field.
If the examiner believes that it would be helpful to cite an analogous court decision, the rejection
could include an explanation of how the claimed mixture is like the novel bacterial mixture of Funk
Brothers, which was held ineligible because each species of bacteria in the mixture (like each
component in the texiol mixture) continued to have “the same effect it always had”, i.e., it lacked
markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131
(1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk
Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”).
While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk
Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk
Brothers, 333 U.S. at 128 n.1.
Practice Note: In this set of facts, the specificity of the amounts of each component in this mixture did
not result in markedly different characteristics of the sweetener. However, under different facts,
other mixtures or combinations with specific amounts may result in markedly different
characteristics or, when viewed as a whole, may result in adding significantly more to the claimed
product of nature. If that is the case, it would be a best practice to indicate why the claim is eligible
by explaining which characteristics are markedly different, and not simply noting that the
percentages or ratios do not occur in nature.
Claim 3: Eligible
The claim recites a dietary sweetener comprising 1-5 percent texiol, at least 90 percent water, and 1-
2 percent Compound N. Based on the specification’s definition of “dietary sweetener”, the broadest
reasonable interpretation (BRI) of the claim is a mixture of texiol, water, and Compound N in the
specified amounts. Because texiol, water, and Compound N are composed of matter, the claim is
directed to a statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.
The claimed mixture is a nature-based product that must be compared to its closest naturally
occurring counterpart to determine if it has markedly different characteristics than the counterpart.
Because texiol, water and Compound N do not occur together in nature, there is no naturally
occurring counterpart mixture for comparison. However, texiol does occur naturally in combination
with water, in the sap of the Texas mint plant. Accordingly, the closest naturally occurring
counterparts to which the claimed mixture is compared are Compound N, and the naturally occurring
texiol-water combination. Each of these components is naturally occurring, so none would be eligible
20 May 2016
Subject Matter Eligibility Examples: Life Sciences
as claimed on its own. There is no indication that mixing these components changes the structure of
the components, and no chemical reaction occurs between or among the components. However, the
mixture has a changed organoleptic property (e.g., taste), because its flavor profile (sweet and lacking
bitterness) is different than the mere sum of the flavors of the individual components, e.g., texiol’s
sweetness and bitter aftertaste, and Compound N’s mild umami flavor. This altered property is a
marked difference in characteristics, because it results in the claimed mixture being distinct from its
natural counterparts in a way that is relevant to the nature of the invention as a dietary sweetener,
e.g., because the taster no longer perceives the bitter aftertaste of naturally occurring texiol. Cf. In re
Roslin Institute (Edinburgh), 750 F.3d 1333, 1339 (2014) (claimed cloned mammals do not have
markedly different characteristics from their naturally occurring counterparts). Thus, the claimed
dietary sweetener has markedly different characteristics as compared to its natural counterparts,
and is not a “product of nature” exception. Accordingly, the claim is not directed to an exception (Step
2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not
performed. Thus, the examiner would not need to evaluate the significantly more considerations for
this claim. If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance, indicating that the claim is not directed to any
judicial exception.
Claim 4: Eligible
The claim recites a dietary sweetener comprising 5 percent texiol, water and/or fruit juice, and
sufficient amounts of pectin to provide a solid gel. Based on the specification’s definition of “dietary
sweetener” and the plain meaning of “solid gel”, the broadest reasonable interpretation of the claim
is a mixture of texiol, pectin, and water that has the form of a solid gel (i.e., has a jelly-like spreadable
consistency). Because the gel is composed of matter, the claim is directed to a statutory category, e.g.,
a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
gel is a nature-based product that must be compared to its closest naturally occurring counterpart to
determine if it has markedly different characteristics than the counterpart. Because texiol, pectin,
and water do not occur together in nature (the Texas mint plant does not contain any pectin), there
is no naturally occurring counterpart mixture for comparison. However, pectin does occur naturally
in combination with water (e.g., in apples), and texiol occurs naturally in combination with water in
the thin liquid sap of the Texas mint plant. Accordingly, the closest naturally occurring counterparts
to which the claimed gel is compared are the naturally occurring water-pectin and texiol-water
combinations. There is no indication that mixing the texiol-water combination with the water-pectin
combination changes the structure of the water or pectin. However, the texiol in the claimed mixture
does have changed properties as compared to naturally occurring texiol in the plant sap, in that the
claimed texiol is present in a solid yet spreadable gel form and has improved organoleptic properties
(e.g., a more pleasant mouthfeel). These altered properties are a marked difference in characteristics,
because they result in the claimed formulation being distinct from its natural counterparts in a way
(jelly-like spreadable consistency and more pleasant mouthfeel) that is relevant to the nature of the
invention as a dietary sweetener, e.g., because the claimed formulation can be spread onto other
foods such as pastry dough, or formed into candies such as jellybeans. Cf. Roslin, 750 F.3d at 1339
(claimed cloned mammals do not have markedly different characteristics from their naturally
occurring counterparts). Because the claimed dietary sweetener formulation thus has markedly
different characteristics as compared to its natural counterpart, it is not a “product of nature”
exception. Accordingly, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible
subject matter.
21 May 2016
Subject Matter Eligibility Examples: Life Sciences
Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not
performed. Thus, the examiner would not need to evaluate the significantly more considerations for
this claim. If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance, indicating that the claim is not directed to any
judicial exception.
Claim 5: Eligible
The claim recites a dietary sweetener comprising granular particles of texiol having a specific particle
size distribution, where X10 is 80 microns and X90 is 300 microns. Based on the specification’s
definition of “dietary sweetener” and the plain meaning of “X10” and “X90”, the broadest reasonable
interpretation of the claim is a texiol formulation having a specific particle size distribution, i.e., 10
percent of the particles have a diameter smaller than 80 microns, 10 percent of the particles have a
diameter greater than 300 microns, and the remaining 80 percent have a diameter between 80 and
300 microns. Because texiol is composed of matter, the claim is directed to a statutory category, e.g.,
a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
texiol formulation having a specific particle size distribution is a nature-based product that must be
compared to its closest naturally occurring counterpart (texiol in its natural irregular crystal state)
to determine if it has markedly different characteristics than the counterpart. As disclosed by
applicant, the specific particle size distribution results in the claimed texiol formulation having a
changed property, i.e., an increased (and consistent) dissolution rate, as opposed to the slow and
inconsistent dissolution rate of naturally occurring texiol. This altered property is a marked
difference in characteristics, because it results in the claimed formulation being distinct from its
natural counterpart in a way (release of sweetness over time) that is relevant to the nature of the
invention as a dietary sweetener, e.g., because the claimed formulation will dissolve evenly and
rapidly in a cool liquid. Cf. Roslin, 750 F.3d at 1339 (claimed cloned mammals do not have markedly
different characteristics from their naturally occurring counterparts). Because it has markedly
different characteristics as compared to its natural counterpart, the claimed formulation is not a
“product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not
performed. Thus, the examiner would not need to evaluate the significantly more considerations for
this claim. If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance, indicating that the claim is not directed to any
judicial exception.
Claim 6: Eligible
The claim recites a dietary sweetener comprising texiol in a controlled release formulation. Based on
the specification’s definition of “dietary sweetener” and the plain meaning of “controlled release
formulation”, the broadest reasonable interpretation of the claim is a texiol formulation that has
altered time release properties so that its sweetness is now released in a controlled manner over
time due to (a) a change in form or structure or (b) being mixed with other substances (e.g., by being
encapsulated in a polymer-emulsifier mixture). In either case, the texiol formulation is composed of
matter, and thus the claim is directed to a statutory category, e.g., a composition of matter (Step 1:
YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed
formulation is a nature-based product that must be compared to its closest naturally occurring
counterpart to determine if it has markedly different characteristics than the counterpart. There is
22 May 2016
Subject Matter Eligibility Examples: Life Sciences
no naturally occurring mixture for comparison, and so the claimed formulation is compared to
naturally occurring texiol in its natural state. As disclosed by applicant, the claimed formulation has
altered time release properties, in that it releases the sweetness of texiol in a controlled manner over
time, as opposed to the naturally occurring texiol, which releases all of its sweetness at one point in
time. These altered properties are a marked difference in characteristics, because they result in the
claimed formulation being distinct from its natural counterpart in a way (release of sweetness over
time) that is relevant to the nature of the invention as a dietary sweetener. Cf. Roslin, 750 F.3d at
1339 (claimed cloned mammals do not have markedly different characteristics from their naturally
occurring counterparts). Because it has markedly different characteristics as compared to its natural
counterpart, the claimed formulation is not a “product of nature” exception. Thus, the claim is not
directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not
performed. Thus, the examiner would not need to evaluate the significantly more considerations for
this claim. If the examiner believes that the record would benefit from clarification, remarks could be
added to an Office action or reasons for allowance, indicating that the claim is not directed to any
judicial exception.
Background
Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence
of the gene in humans), and has also discovered naturally occurring alterations from the wild-type
sequence that are correlated with an increased likelihood of developing breast or ovarian cancer.
Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by
comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared
sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.
At the time the invention was made and the application was filed, scientists routinely compared DNA
sequences using two data-gathering techniques. The first technique seeks to hybridize two different
DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detects whether the
molecules bind to each other and form a hybridization product. The second technique amplifies
(makes copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by
using a set of primers to produce amplified nucleic acids, and then sequences the amplified nucleic
acids. The probes and primers used in these techniques are short single-stranded DNA molecules
that typically have a naturally occurring nucleotide sequence, for example a probe to the BRCA1 gene
23 May 2016
Subject Matter Eligibility Examples: Life Sciences
may have a nucleotide sequence that is identical to a portion of the germline sequence of the wild-
type BRCA1 gene.
In one embodiment, applicant discloses using a computer-implemented micromechanical method
known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe
to its target. SNOM is a technique that achieves high spatial resolution of a nanometric sample, using
a laser and optical microscope that are controlled by a computer. At the time the invention was made
and the application was filed, the use of SNOM to study DNA hybridization had been discussed in
several articles in widely-read scientific journals. However, scientists were not commonly or
routinely using SNOM to study DNA hybridization at the time the invention was made and the
application was filed. Instead, scientists at the time typically used autoradiography to detect
hybridization products.
In another embodiment, applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt
PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and
annealing temperatures than conventional PCR. Because these lower temperatures result in
preferential amplification of mutant nucleic acids as compared to wild-type nucleic acids, Cool-Melt
PCR has a 20-fold higher sensitivity of mutation detection than conventional PCR. At the time the
invention was made and the application was filed, Cool-Melt PCR was known and used by a few
scientists in the field. Several years after filing the application, Cool-Melt PCR became a standard
laboratory technique that appeared in virtually every laboratory manual and was conventionally
used by most scientists in the field to amplify mutant nucleic acids.
Claims
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which
comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue
sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample
with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type
BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1
cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
detecting the presence of a hybridization product by measuring conformational changes in
the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field
optical microscopy.
80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of
primers to produce amplified nucleic acids; and
24 May 2016
Subject Matter Eligibility Examples: Life Sciences
Analysis
Claim 1: Ineligible.
The claim recites a step or act, i.e., comparing the patient’s genetic sequence with wild type genetic
sequences. Thus, the claim is directed to a process, which is one of the statutory categories of
invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claim
recites a step of comparing the patient’s BRCA1 sequence with wild-type BRCA1 sequences, and a
wherein clause stating the result of the comparison, which is that a difference in the compared
sequences indicates that the patient has an alteration in the BRCA1 gene. This step of comparing is
recited at a high level of generality that merely requires a comparison of two pieces of information
and imposes no limits on how the comparison is performed. In Myriad CAFC, the court found this step
of comparing to be an abstract idea.
When applying the 2014 IEG and interpreting the claim during examination, it is apparent that the
step of comparing could be performed by a human using mental steps or basic critical thinking.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and
comparing known information in Classen, or comparing information regarding a sample or test
subject to a control or target data in Ambry and Myriad CAFC. The specific information that is being
compared (sequences of a BRCA1 gene, BRCA1 RNA, or BRCA1 cDNA with wild-type sequences)
merely narrows the abstract idea, which does not make the comparison step less abstract and is not
sufficient to provide eligibility on its own. Thus, the claim is directed to an abstract idea (Step 2A:
YES).
Note that although nature-based product limitations are recited in the claim (e.g., genes), analysis of
the claim as a whole indicates that this claim is focused on a process of comparing information about
the products, and is not focused on the products per se. Thus, there is no need to perform the
markedly different characteristics analysis on the recited nature-based product limitations in this
claim.
Next, the claim as a whole is analyzed to determine whether any additional element, or combination
of elements, is sufficient to ensure that the claim amounts to significantly more than the abstract idea.
The claim recites a single step of comparing, along with a wherein clause, all of which were identified
as the abstract idea explained above. There are no other elements/steps recited in the claim.
Accordingly, the claim as a whole does not amount to significantly more than the abstract idea of
comparing information (Step 2B: NO). The claim is not patent eligible.
A rejection of claim 1 should identify the exception by pointing to the comparison of sequences in the
claim and explain that this type of comparison of information has been held by the courts to be an
abstract idea and that limits on the type of information being compared merely narrow the abstract
idea. The rejection should also identify that there are no additional elements/steps in the claim. For
clarity, the rejection can explain why the wherein clause does not impose any additional limitations
on the claimed method, but merely breathes meaning into the comparison step by stating the result
of the comparison.
25 May 2016
Subject Matter Eligibility Examples: Life Sciences
26 May 2016
Subject Matter Eligibility Examples: Life Sciences
step in which conformational changes in the gene probe that are indicative of hybridization with the
patient’s BRCA1 gene are measured by scanning near-field optical microscopy (SNOM). These steps
do not recite or describe any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus
Labs., 566 U.S. __, 132 S. Ct. 1289, 1297 (2012) (recited steps of administering a drug to a patient and
determining the resultant level of 6-thioguanine in the patient “are not themselves natural laws”).
Accordingly, the claim is not directed to an exception (Step 2A: NO), and is eligible.
Note that although nature-based product limitations are recited in the claim (e.g., the probe and
BRCA1 gene), analysis of the claim as a whole indicates that the claim is focused on a process of
detecting whether the probe has hybridized to the BRCA1 gene, and is not focused on the products
per se. Thus, there is no need to perform the markedly different characteristics analysis on the recited
nature-based product limitations. In addition, note that because the analysis of this claim ends with
eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would
not need to evaluate the significantly more considerations for this claim.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
27 May 2016
Subject Matter Eligibility Examples: Life Sciences
amplifying using Cool-Melt PCR yields a claim as a whole that is significantly more than the judicial
exception itself (Step 2B: YES). The claim recites patent eligible subject matter.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that the claim recites the abstract idea of
comparing sequence information. However, the claim is eligible because it recites additional
limitations that when considered as a combination are more than a mere instruction to “apply” the
abstract idea using well-understood, routine or conventional techniques in the field.
Background
Fourdrinier machines are used to make paper from a slurry of wood pulp mixed with water (called
“stock”). The paper-forming section of the machines typically comprises a headbox that feeds the
stock onto one end of a conveyor belt called a “paper-making wire”, which is passed over a series of
rolls at a constant speed. The belt carries the stock from the headbox end of the machine (called the
“breast-roll end”) to the other end (called the “couch-roll end”), while simultaneously draining and
shaking the stock to form a continuous paper web. The paper web is then passed into the press
section of the machine for further processing.
28 May 2016
Subject Matter Eligibility Examples: Life Sciences
At the time applicant made the invention and filed the application, it was routine and conventional
to arrange the paper-making wire so that the breast-roll end was at the same or a lower height than
the couch-roll end, and to feed the stock from the headbox onto the paper-making wire at a speed
substantially slower than the wire speed. However, this arrangement necessitated running the
machine at an overall slow speed (less than 500 feet/minute) in order to avoid undesirable effects
(e.g., waves, wrinkles and ripples) on the quality of the paper web.
Applicant’s invention is a Fourdrinier machine that solves the problem of running the process at a
slow speed by raising the breast-roll end of the paper-making wire to a height substantially above
the couch-roll end, and by using gravity to feed the stock into the machine at a speed approximately
equal to the wire speed. This gravity-fed arrangement permits applicant’s machine to be run at an
overall speed that is much higher (e.g., more than 700 feet/minute) than conventional machines,
without producing undesirable effects on the quality of the paper web.
Hypothetical Claim
1. A Fourdrinier machine having a breast-roll end of a paper-making wire maintained at a
substantial elevation above level, whereby stock is caused to travel by gravity, rapidly, in the
direction of movement of the paper-making wire, and at a speed approximately equal to the
speed of the paper-making wire.
Analysis
Claim 1: Eligible.
The claim recites a Fourdrinier machine with a paper-making wire (conveyor belt) that is passed
over a breast-roll. The claim is directed to a machine (a combination of mechanical parts), which is
one of the statutory categories of invention (Step 1: YES).
Next, the claim must be evaluated to determine if the claim is directed to a judicial exception. But
when the claim is reviewed, it is immediately evident that although the claimed machine operates
using gravity, which is a law of nature, the claim clearly does not seek to tie up this law of nature so
that others cannot utilize it. In particular, the claim’s recitation of a Fourdrinier machine (which is
understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a
series of rolls) that is arranged in a particular way to optimize the speed of the machine while
maintaining quality of the formed paper web makes it clear that the claim as a whole would clearly
amount to significantly more than any recited exception. The claim as a whole adds meaningful
limitations to the use of the law of nature (gravity). Additionally, use of the law of nature improves
paper-making technology. Thus, eligibility of the claim is self-evident for these reasons, and there is
no need to perform the full eligibility analysis (e.g., Steps 2A and 2B). The claim is patent eligible.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance indicating that while the claim recites gravity - a law of
nature - the claim clearly amounts to significantly more than the mere use of gravity by providing
meaningful limitations to the law of nature and additionally improving paper-making technology.
It is noted that although Eibel Process Co. was decided prior to the 1952 Patent Act, the Supreme
Court has subsequently described the decision as upholding the eligibility of process claims
containing a law of nature. See, e.g., Diamond v. Diehr, 450 U.S. 175, 187-88 (1981); Parker v. Flook,
437 U.S. 584, 590-91 and n.12 (1978).
29 May 2016
Subject Matter Eligibility Examples: Life Sciences
Background
Fats are naturally occurring chemicals that are found in many plants and animals, e.g., in tree nuts
such as walnuts. As shown in Figure 1, each fat molecule comprises a glycerol backbone to which
three fatty acid chains are bound.
As also shown in Figure 1, fat molecules can be broken down into free fatty acids and glycerol (also
called glycerine) via a chemical reaction. At the time applicant made the invention and filed the
application, it was routine and conventional to carry out this chemical reaction using either the
alkaline saponification process, or the sulphuric-acid distillation process. Both of these conventional
processes required the use of a steam distillation step in order to produce free fatty acids, and also
required the fat to be mixed with either lye or sulphuric acid.
Applicant invented a process of hydrolyzing fat molecules into free fatty acids and glycerol without
steam distillation, and using only water as opposed to lye or sulphuric acid. This hydrolysis process
begins with a mixture of substantially equal quantities of fat and water in a vessel that is closed and
strong enough to resist the effort of the mixture to convert itself into steam. The mixture is then
gradually heated to a high temperature (at least 600 degrees Fahrenheit) and kept at that
temperature for at least 10 minutes, so that a chemical reaction takes place between the water and
fat. While it is heated, the mixture is also subjected to sufficient pressure to prevent the water-fat
mixture from forming steam inside the closed vessel.
Hypothetical Claim
1. A process for obtaining free fatty acids and glycerol from fat comprising:
mixing substantially equal quantities of fat and water in a closed vessel; and
30 May 2016
Subject Matter Eligibility Examples: Life Sciences
heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit under
sufficient pressure to prevent the formation of steam in the closed vessel; and
maintaining the elevated temperature for at least 10 minutes so that the fat and water react
with each other to form free fatty acids and glycerol.
Analysis
Claim 1: Eligible.
The claim recites a series of steps for mixing and heating fat and water. Thus, the claim is directed to
a process, which is one of the statutory categories of invention (Step 1: YES).
Next, the claim must be evaluated to determine if the claim is directed to a judicial exception. But
when the claim is reviewed, it is immediately evident that although the claim is founded upon a
chemical principle relating to neutral fats, it is not attempting to tie up any judicial exception so that
others cannot practice it. In particular, the claim’s description of mixing substantially equal quantities
of fat and water, heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit
under sufficient pressure to prevent the formation of steam in the closed vessel, and maintaining the
elevated temperature for at least 10 minutes so that the fat and water react with each other to form
free fatty acids and glycerol, makes it clear that the claim as a whole would clearly amount to
significantly more than any potential recited exception. For example, the claim as a whole effects a
transformation of the fat and water into different chemicals, i.e., from fat and water into the fatty
acids and glycerol, by means of specific and unconventional steps. Thus, eligibility of the claim is self-
evident in the streamlined analysis, without needing to perform the full eligibility analysis (e.g., Steps
2A and 2B). The claim is patent eligible.
It is important to point out as well that there is no apparent exception recited in the claim, which
alone would be sufficient for eligibility. Although the claim is clearly based upon a law of nature (the
chemical principle or scientific fact that the elements of neutral fat require that they be severally
united with an atomic equivalent of water in order to separate from each other and become free), the
law of nature is not recited in the claim. The cases in which courts found claims directed to laws of
nature are those in which the law is recited in the claim as part of the invention, such as when the
claim sets forth or describes a naturally occurring principle.
If the examiner believes that the record would benefit from clarification, remarks could be added to
an Office action or reasons for allowance, indicating that the claim is not directed to any judicial
exception.
It is noted that although Tilghman was decided prior to the 1952 Patent Act, the Supreme Court has
subsequently described the decision as upholding the eligibility of process claims containing a law of
nature. See, e.g., Parker v. Flook, 437 U.S. 584, 590-91 and n.12 (1978); Gottschalk v. Benson, 409 U.S.
63, 70 (1972).
31 May 2016
Subject Matter Eligibility Examples: Business Methods
The following examples should be used in conjunction with the 2014 Interim Guidance on Subject
Matter Eligibility (2014 IEG) and the follow‐on guidance. As the examples are intended to be
illustrative only, they should be interpreted based on the fact patterns set forth below. Other fact
patterns may have different eligibility outcomes. While some of the fact patterns draw from U.S.
Supreme Court or U.S. Court of Appeals for the Federal Circuit decisions, each of the examples shows
how claims should be analyzed under the 2014 IEG. All of the claims are analyzed for eligibility in
accordance with their broadest reasonable interpretation. Citations for the cases discussed in these
examples are provided in the chart of court decisions available on the Office’s website.
Note that the examples herein are numbered consecutively beginning with number 34, because 33
examples were previously issued.
Background
Applicant has invented a system for filtering content from an Internet computer network by an
Internet Service Provider (ISP) server using individual controlled access network accounts. At the
time of applicant’s invention in 1997, there was a need to block access to certain web sites for certain
end users. For example, a corporation may want to allow access to certain technical or business sites,
while blocking access to certain entertainment sites, and a parent may seek to block access by their
children to certain objectionable sites.
Previous systems controlled access to content received by client machines over the Internet by
filtering the information available using “black‐listing” (i.e., preventing access to all web sites on a
predetermined list of web sites), “white‐listing” (i.e., allowing access to all web sites that are on a
predetermined list of web sites), or word‐screening or phrase‐screening (i.e., preventing access to a
web page that contains any word or phrase on a predetermined list). Initially, the filtering software
was placed on a client computer. However, this configuration suffered from several disadvantages
because the end user could modify or work around the filtering software, the difficulty and time to
install on each client computer was great, each client computer required configuration of the
software based on its hardware and operating system, and a database storing the allowed or
disallowed websites needed to be frequently updated. To overcome the disadvantages of installing
the filtering software on a client computer, the filtering software was placed on a local server. In this
configuration, client computers on a local area network connected to the Internet through a local
server. If an end user on a client computer requested a website on the Internet, the local server would
filter all requests for Internet content. This approach suffered from similar disadvantages including
being limited to one set of filtering criteria, time‐consuming installation and maintenance, and the
filtering software being tied to one local area network or local server platform. Finally, ISPs used a
server‐based configuration in which a filter was installed on their remote servers to prevent
December 2016 1
Subject Matter Eligibility Examples: Business Methods
subscribers from accessing certain websites. However, this configuration only allowed for a single
set of filtering criteria for all of the subscriber’s end users.
In the instant application, applicant’s system improves upon the prior art filtering systems by
providing a system for filtering Internet content by subscribers on an individually customizable basis.
An ISP server stores a filtering scheme in memory and a database of a plurality of sets of filtering
elements associated with individual end users. The filtering scheme is executable code, including
object code, interpreted code (e.g., Java™ or Javascript™), other high‐level code, or a combination
thereof. The ISP server associates an end user account with a set of filtering elements from a plurality
of filtering elements (e.g., a master list of words or phrases that are not allowed) and one or more
filtering schemes (e.g., a word‐screening type or phrase‐screening type filtering scheme).
In applicant’s system, the ISP server receives a log‐in request from an end user. After verifying the
identity of the end user, the ISP server determines the filtering scheme and filtering elements
associated with the end user based on the end user account. The ISP server then receives a request
to access a website from the end user and identifies the particular website requested. The ISP server
implements the filtering scheme associated with the end user account utilizing the customized
filtering elements that are associated with the end user account. The ISP server then determines
whether the filtering scheme authorizes the request. If the request is authorized, it is processed and
forwarded to the Internet. If it is not authorized, the ISP server provides a rejection notice to the end
user.
In one embodiment, a request to access the Internet from an end user is partially processed while the
ISP server monitors the content for certain words or phrases using the filtering scheme (e.g., a word‐
screening or phrase‐screening scheme). In this embodiment, the ISP server stores a table of logged‐
in end users associated with the filtering scheme. The request for Internet access is forwarded
directly to the Internet. The ISP server then monitors all data packets transmitted to the ISP server
to determine which packets will be forwarded to the end users stored in the table. If a data packet is
being sent to a user stored in the table, the ISP server screens the packet based on the filtering scheme
and filtering elements associated with that end user’s account. If the data packet(s) match the
filtering elements of the filtering scheme, such as by containing specific words or phrases, the
transmission of the data packet(s) to the user is terminated.
Representative Claim
1. A content filtering system for filtering content retrieved from an Internet computer network by
individual controlled access network accounts, said filtering system comprising:
a local client computer generating network access requests for said individual controlled
access network accounts;
at least one filtering scheme;
a plurality of sets of logical filtering elements; and
a remote ISP server coupled to said client computer and said Internet computer network,
said ISP server associating each said network account to at least one filtering scheme and at least
one set of filtering elements, said ISP server further receiving said network access requests from
said client computer and executing said associated filtering scheme utilizing said associated set of
logical filtering elements.
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Subject Matter Eligibility Examples: Business Methods
Analysis
Claim 1: Eligible
The claim recites a local client computer and a remote ISP server that implements at least one
filtering scheme and a plurality of sets of logical filtering elements. The system comprises a device
or set of devices and, therefore, is a machine, which is a statutory category of invention (Step 1: YES).
The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim
recites a system for filtering content retrieved from an Internet computer network, which generates
access requests for individual accounts, associates each account with at least one filtering scheme
and at least one set of filtering elements from a plurality of sets of filtering elements, receives the
access requests, and executes the associated filtering scheme utilizing the associated set of filtering
elements. Thus, the focus of the claim and its character as a whole is on the idea of filtering content,
which is implemented by a system that uses computer and networking components.
Filtering content is according to the court a “method of organizing human behavior” that is similar to
other concepts that have been identified as abstract by the courts, such as tracking financial
transactions to determine whether they exceed a pre‐set spending limit in Intellectual Ventures I v.
Capital One Bank; 1) collecting data, 2) recognizing certain data within the collected data set, and 3)
storing that recognized data in a memory in Content Extraction; and organizing information through
mathematical correlations in Digitech. Therefore, it is reasonable to conclude based on the similarity
of the idea described in this claim to several abstract ideas found by the courts that claim 1 is directed
to an abstract idea (Step 2A: Yes).
This conclusion is not altered by Enfish, where the Federal Circuit stated that certain claims directed
to improvements in computer‐related technology, including claims directed to software, are not
necessarily abstract (Step 2A). Unlike the claims in Enfish, claim 1 is not clearly directed to an
improvement in computer‐related technology (e.g., computer functionality). Thus, because it is not
readily apparent that claim 1 is directed to a non‐abstract idea under Step 2A, it is necessary to
analyze the additional elements in claim 1 under Step 2B.
It is noted, however, that the Federal Circuit in BASCOM described claim 1 as presenting a “close call” as
to what it is directed to. Thus, if an examiner skilled in this art recognizes that the claim is directed to
an Internet‐centric problem, for example, or clearly to an improvement in the computer technology of
filtering, it would be appropriate to find that the claim, while “involving” an abstract idea is not
“directed” to that idea standing alone, thus ending the analysis with a finding of eligibility at Step 2A.
Under Step 2B, the claim as a whole is analyzed to determine whether any element, or combination
of elements, is sufficient to ensure the claim amounts to significantly more than the abstract idea.
The claim recites the additional limitations of 1) controlled access network accounts, 2) a local client
computer to generate network access requests for the controlled access network accounts, 3) an
Internet computer network, and 4) a remote ISP server coupled to the client computer and the
Internet computer network. The remote ISP server associates each account with at least one filtering
scheme and at least one set of filtering elements from a plurality of sets of filtering elements, receives
the access requests, and executes the associated filtering scheme utilizing the associated set of
filtering elements. The local computer, ISP server, Internet computer network, and controlled access
network account are generic computer and networking components performing generic computer
and networking functions at a high level of generality. As the Federal Circuit determined, these
limitations do not amount to significantly more when “taken individually, [because they] recite
generic computer, network and Internet components, none of which is inventive by itself.”
However, the analysis under Step 2B (also called the “inventive concept inquiry”) requires more than
determining that each additional claim element – the controlled access network accounts, a local
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Subject Matter Eligibility Examples: Business Methods
client computer, an Internet computer network, and a remote ISP server – is well known by itself.
Here, an inventive concept can be found in the unconventional and non‐generic combination of
known elements, and more specifically “the installation of a filtering tool at a specific location, remote
from the end‐users, with customizable filtering features specific to each end user” where the filtering
tool at the ISP is able to “identify individual accounts that communicate with the ISP server, and to
associate a request for Internet content with a specific individual account.” The Federal Circuit also
determined that the claimed arrangement of elements in the system results in an improvement in the
technology of filtering content on the Internet, because it offers “both the benefits of a filter on the
local computer, and the benefits of a filter on the ISP server.”
Further, these limitations confine the abstract idea to a particular, practical application of the
abstract idea and, as explained in the specification, this combination of limitations is not well‐
understood, routine or conventional activity. Unlike the claimed system, previous content filtering
systems were able to be modified by end users when the systems were located on local client
computers rather than on the ISP server and were dependent on hardware and software on the local
computer, or limited to a configuration based on the particular local client computer, local server, or
ISP server. In addition, these limitations do not simply recite an instruction to apply the abstract idea
of filtering content on the Internet or to perform the abstract idea on a generic set of computers.
Instead, the claim recites a “technology‐based solution” of filtering content on the Internet that
overcomes the disadvantages of prior art filtering systems. Thus, when viewed as an ordered
combination, the claim limitations amount to significantly more than the abstract idea of content
filtering (Step 2B: Yes). The claim is patent eligible.
In practice, if an examiner believes the record would benefit from clarification, remarks could be
added to the Office action or reasons for allowance indicating that the claim recites the abstract idea
of filtering content. However, the claim is eligible because analyzing the claim limitations as an
ordered combination demonstrates that the claim is a particular application of and an improvement
to the technology of filtering content on the Internet, rather than well‐understood, routine,
conventional activity or a simple instruction to apply the abstract idea of filtering content on the
Internet or to perform the abstract idea on a generic set of computers.
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Subject Matter Eligibility Examples: Business Methods
techniques” and was not a “technology‐based solution” of the abstract idea. Claim 1 of BASCOM
presents a “technology‐based solution” of filtering content on the Internet that overcomes the
problems in the prior art with other Internet content filtering systems as discussed above.
Finally, the claims in Intellectual Ventures I, Content Extraction, Ultramercial, and Accenture are
directed to an abstract idea performed on generic computer components, “without providing a
specific technical solution beyond simply using generic computer concepts in a conventional way.”
In Intellectual Ventures I, the claims were directed to the abstract idea of tracking financial
transactions to determine whether they exceed a pre‐set spending limit simply implemented on a
generic computer and the Internet. In Content Extraction, the claims were directed to the abstract
idea of collecting data, recognizing certain data within the collected data set, and storing that
recognized data in a memory performed on generic scanning devices and computers. In Ultramercial,
the claims were directed to the abstract idea of using advertising as an exchange or currency on the
Internet. And finally, the claims in Accenture were directed to the abstract idea of generating rule‐
based tasks for processing an insurance claim using generic computer components performing
conventional activities. Unlike the claims in Intellectual Ventures I, Content Extraction, Ultramercial,
and Accenture, claim 1 of BASCOM is not simply directed to the abstract idea of filtering content on
the Internet or on generic computer components performing conventional activities. Instead, claim
1 “carve[s] out a specific location for the filtering system (a remote ISP server) and require the
filtering system to give users the ability to customize filtering for their individual network accounts.”
Background
Financial institutions routinely provide automated teller machines (ATMs) for customers to conduct
banking transactions at convenient locations other than brick‐and‐mortar banks, and without the
need to interact with a bank teller. Typical ATMs include a customer interface with a keypad, function
key, display, outlet slot for statements or other information, cash dispenser slot, deposit inlet, and
often a speaker to provide customer voice guidance and a camera to monitor transactions. A reader
is provided for customers to present data bearing records, which can include data corresponding to
the customer, financial accounts, or other data, and are commonly embodied as a bank card with a
magnetic strip or a contactless card with a radio frequency identification (RFID) tag. Other input
devices, such as a biometric reader to receive customer identifying inputs such as fingerprints, iris
scans, and face topography data, a camera, or speech recognition device, used to identify a user can
be provided as well. The customer interface is coupled to a controller with a processor and memory
and a network communicator to enable communication between the controller and a financial
institution to exchange information about the transactions. To conduct a transaction, a customer
typically inserts a bank card into the appropriate slot in the ATM and inputs a personal identification
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Subject Matter Eligibility Examples: Business Methods
number (PIN) that verifies that the user is an authorized user for the bank account associated with
the bank card. The account data is read from the card using the reader in the ATM and the PIN
associated with the card. The network communicator transmits the read data and PIN to a remote
computer at the financial institution, which then transmits instructions back to the ATM regarding
authorization to carry out the requested transaction.
Due to its speed and convenience, the use of ATMs to conduct banking business has become
ubiquitous, but so have problems with theft and fraud. For example, if another person illegally or
fraudulently obtains a user’s PIN, that person can gain access to funds in the account. Another
problem associated with ATMs is “skimming” where a false card reader that appears to be a
legitimate reader is affixed to an ATM to obtain an authorized user’s account information and PIN. In
skimming operations, an authorized user unwittingly presents their bank card to the skimming
device on the ATM and enters their PIN, which is then captured and stored for subsequent fraudulent
activity.
There have been various solutions attempting to reduce the instance of fraud associated with ATMs
and to improve security when verifying an authorized user. For example, some bank cards are
provided with chips that interact with a special reader to generate a unique transaction number each
time a transaction is conducted to reduce the chance that a user’s account information and PIN can
be stolen for later use (so‐called “chip and pin” cards). Bank cards have also been outfitted with RFID
tags or “smart labels” (non‐contact transponders) that allow account information to be transmitted
to an ATM without inserting the card into the machine, and thus exposing it to theft or skimming.
The smart label can contain various types of customer information, including profile data,
preferences, and unique customer identification data. To conduct a transaction using such a
contactless card, the customer brings the card into range of an ATM reader, which uses radio
frequencies to interrogate the smart label to receive information about the customer. The
interrogation can be encrypted to provide additional security. The customer can then start a
transaction, e.g., by pressing an enter key on the ATM. While such cards can prevent fraud based on
skimming, these non‐contact cards have given rise to other security issues, such as allowing a
malicious person to obtain card information by use of an unauthorized RFID reader.
Applicant has invented a method of ensuring secure transmission of data from a card using a smart
label and encryption techniques. The invention leverages the wide‐spread use of mobile personal
communication devices (smart phones) to facilitate the secure transmission. When a customer is
issued a bank card with a smart label, the financial institution also provides a downloadable software
application to the customer to install on their mobile communication device. The software
application is designed to assist communication with a specially outfitted ATM.
The ATM in accordance with this invention includes a controller that is programmed with a time‐
variant random code generator. The code generator generates a random code when activated in
response to the reader receiving data from the customer’s bank card. In other words, when the
customer is within a certain range of the ATM with their bank card, the smart label is read from the
RFID reader in the ATM, which signals the code generator to generate a time‐variant random code,
which can be a plurality of digits, numbers and/or letters. The ATM then provides the random code
to the customer. In one embodiment, the ATM provides the random code by displaying it. The
customer is prompted to enter the displayed code into their mobile device, which already has the
institutional software installed. In another embodiment, the random code is transmitted by the ATM
to the customer’s mobile device, e.g., by a near‐field communication or Bluetooth link, if the customer
has installed the institutional software on their mobile device and registered their mobile device with
the institution.
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Subject Matter Eligibility Examples: Business Methods
The software provided by the institution generates data in response to the random code, which may
be, e.g., a customer confirmation code or an encryption that includes the code data and the card’s
data. The software then causes the mobile device to communicate the responsive data to the ATM.
In one embodiment, the mobile device displays the encrypted data as an image on its display screen.
The image can be machine readable data in the form of a bar code or an image such as a colored
pattern. The customer is prompted to allow the ATM to scan the image displayed by the mobile
device. The reader of the ATM reads the encrypted image and verifies that it is authentic by, for
example, determining if it is readable, recognizable, or properly formatted. Once verified, the
processor in the ATM decrypts the data and confirms that the decrypted code matches the random
code that was generated for the current transaction session. In another embodiment, the customer
confirmation code is obtained by the ATM (e.g., by transmission over near‐field communication or
Bluetooth link), and the ATM then confirms that the customer confirmation code matches the random
code. The outcome of the comparison between the responsive code data (e.g., the decrypted code or
the customer confirmation code) and the random code is used to control access to the keypad. In
particular, if the responsive code data and the generated code match and the elapsed time is within
a certain time frame, the transaction is continued in conventional fashion with the customer entering
a PIN using the keypad. If the responsive code data and generated code do not match or the elapsed
time exceeds the time frame, a signal is sent to lock the keypad so that any attempts at entering a PIN
will be futile.
Applicant’s method allows the ATM to receive user card data in a more secure and efficient manner.
Customer card data entry begins before PIN entry and verification, so if the ATM user is not the
authorized customer and does not have the appropriate verification software on their mobile device,
the transaction is concluded before entry of the PIN. This method prevents skimming and other
techniques to fraudulently obtain a customer’s PIN and even theft of the card since the downloaded
software can authenticate the user and likewise authenticate the ATM before the PIN is produced.
Claims
1. A method of conducting a secure automated teller transaction with a financial institution by
authenticating a customer’s identity, comprising the steps of:
obtaining customer‐specific information from a bank card,
comparing, by a processor, the obtained customer‐specific information with customer
information from the financial institution to verify the customer’s identity, and
determining whether the transaction should proceed when a match from the comparison verifies
the authenticity of the customer’s identity.
December 2016 7
Subject Matter Eligibility Examples: Business Methods
Analysis
Claim 1: Ineligible
The claim recites a method of conducting a secure automated teller transaction comprising a series
of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:
Yes).
The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim
recites the steps of obtaining customer‐specific information, comparing the obtained customer‐
specific information with customer information from the financial institution to authenticate the
customer’s identity, and determining whether the transaction should proceed when a match from
the comparison verifies the authenticity of the customer’s identity. These steps describe a method
of fraud prevention by verifying the authenticity of the customer’s identity prior to proceeding with
a banking transaction, which is a “long prevalent” business practice that bank tellers have used for
many years. Fraud prevention by verifying the identity of the customer is as fundamental to business
as the economic concepts that were identified as abstract ideas by the Supreme Court, such as
intermediated settlement (Alice Corp.) and risk hedging (Bilski). The claim as a whole is also similar
to the claimed invention in CyberSource, which the Federal Circuit described as directed to an
abstract mental process for detecting fraud by obtaining and comparing intangible data pertinent to
business risks. The method of claim 1 similarly recites steps of obtaining and comparing data
pertinent to business risks. More particularly, it describes a method of fraud prevention by
authenticating a customer’s identity. Therefore, claim 1 is directed to an abstract idea (Step 2A: Yes).
December 2016 8
Subject Matter Eligibility Examples: Business Methods
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to
the steps that describe the abstract idea of preventing fraud through verifying a customer’s identity,
the claim recites the additional limitation of obtaining customer‐specific information from a bank
card. This additional element taken individually represents a conventional action of an ATM, as
evidenced by the discussion of the prior art in the background specification. Further, the step is
recited at a high level of generality such that it amounts to insignificant pre‐solution activity, e.g., a
mere data gathering step necessary to use the abstract idea. The claim also recites the additional
element of a processor comparing data. This processor is no more than a generic computer
component, and the comparison performed by the processor does not represent any computer
function beyond what processors typically perform. Taken individually therefore, the additional
elements of claim 1 do not provide significantly more, i.e., an inventive concept, to the claim.
Looking at the combination of elements in claim 1 also fails to show an inventive concept. Unlike the
eligible claims in Diehr and Bascom, in which the elements limiting the exception were individually
conventional but taken together provided an inventive concept because they improved a technical
field, the claim here does not invoke any of the considerations that courts have identified as providing
significantly more than an exception. The combination of elements is no more than the sum of their
parts, and provides nothing more than mere automation of verification steps that were in years past
performed mentally by tellers when engaging with a bank customer. Mere automation of an
economic business practice does not provide significantly more (i.e., provide an inventive concept).
For these reasons, claim 1 is ineligible (Step 2B: No).
A rejection of claim 1 should identify the abstract idea by pointing to the language of the claim that
describes fraud prevention by identity verification (i.e., obtaining customer information, comparing
the obtained customer information to customer information from a financial institution, and
determining whether the transaction should proceed when a match from the comparison verifies the
authenticity of the customer’s identity) and explaining that fraud prevention by identity verification
is similar to concepts that courts have previously found abstract. The rejection should identify the
additional limitations regarding obtaining customer‐specific information from a bank card and a
processor that compares data, and explain why those limitations are conventional or are only generic
computer components performing generic functions and are mere automation of economic business
practices.
Claim 2: Eligible
The claim recites a method of conducting a secure automated teller transaction comprising a series
of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:
Yes).
The claim is then analyzed to determine if the claim is directed to a judicial exception. Claim 2 recites
steps of obtaining customer‐specific information, comparing the obtained customer‐specific
information with customer information from the financial institution to authenticate the customer’s
identity, and determining whether the transaction should proceed when a match from the analysis
verifies the authenticity of the customer’s identity. Like the steps of obtaining and comparing
customer information in claim 1, these steps in claim 2 describe a method of fraud prevention by
identity verification before proceeding with a banking transaction, which as explained above is a
fundamental business practice and is similar to ideas found abstract by the courts. Therefore, claim
2 is directed to an abstract idea (Step 2A: Yes).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to
December 2016 9
Subject Matter Eligibility Examples: Business Methods
the steps that describe the abstract idea of preventing fraud through identity verification, the claim
recites the additional limitations of obtaining customer‐specific information from a bank card, a
processor comparing data, generating a random code and transmitting it to the customer’s mobile
communication device, and the processor reading an image that was generated by the customer’s
mobile communication device in response to receipt of the random code, where the image includes
encrypted code data. The encrypted code data from the image is then used by the processor to verify
the customer’s identity by decrypting the code data and analyzing the decrypted code data.
Considered individually, the steps of obtaining information from a bank card and the comparing data
do not provide significantly more for the same reasons as in claim 1. Similarly, the processor and the
mobile communication device are recited at a high level of generality and perform programmed
functions that represent conventional and generic operations for these devices, including reading
data, generating random codes, and analyzing data.
However, the combination of the steps (e.g., the ATM providing a random code, the mobile
communication device’s generation of the image having encrypted code data in response to the
random code, the ATM’s decryption and analysis of the code data, and the subsequent determination
of whether the transaction should proceed based on the analysis of the code data) operates in a non‐
conventional and non‐generic way to ensure that the customer’s identity is verified in a secure
manner that is more than the conventional verification process employed by an ATM alone. In
combination, these steps do not represent merely gathering data for comparison or security
purposes, but instead set up a sequence of events that address unique problems associated with bank
cards and ATMs (e.g., the use of stolen or “skimmed” bank cards and/or customer information to
perform unauthorized transactions). Thus, like in BASCOM, the claimed combination of additional
elements presents a specific, discrete implementation of the abstract idea. Further, the combination
of obtaining information from the mobile communication device (instead of the ATM keypad) and
using the image (instead of a PIN) to verify the customer’s identity by matching identification
information does not merely select information by content or source, in contrast to Electric Power,
but instead describes a process that differs from the routine and conventional sequence of events
normally conducted by ATM verification, such as entering a PIN, similar to the unconventional
sequence of events in DDR. The additional elements in claim 2 thus represent significantly more (i.e.,
provide an inventive concept) because they are a practical implementation of the abstract idea of
fraud prevention that performs identity verification in a non‐conventional and non‐generic way, even
though the steps use well‐known components (a processor and mobile communication device).
Claim 2 is eligible (Step 2B: Yes).
While an examiner would not be required to provide an explanation of eligibility, the record would
be enhanced if clarifying remarks were provided to point to the reason for eligibility. In this instance,
clarification could easily be made by simply pointing to the combination of elements used in the non‐
conventional implementation of identity verification in the method of fraud prevention.
Claim 3: Eligible
The claim recites a method of conducting a secure automated teller transaction comprising a series
of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:
Yes).
The claim is then analyzed to determine if the claim is directed to a judicial exception. Claim 3 recites
steps of obtaining customer‐specific information, comparing the obtained customer‐specific
information with customer information from the financial institution to authenticate the customer’s
identity, and permitting the transaction to proceed when a match from the analysis verifies the
authenticity of the customer’s identity, and terminating the transaction when there is no match. Like
the steps of obtaining and comparing customer information in claim 1, these steps in claim 3 describe
December 2016 10
Subject Matter Eligibility Examples: Business Methods
a method of fraud prevention by identity verification before proceeding with a banking transaction,
which as explained above is a fundamental business practice and is similar to ideas found abstract by
the courts. Therefore, claim 3 is directed to an abstract idea (Step 2A: Yes).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to
the steps that describe the abstract idea of preventing fraud through identity verification, the claim
recites the additional limitations of obtaining customer‐specific information from a bank card, a
processor comparing data, the ATM generating a random code and visibly displaying it on a customer
interface, and the ATM obtaining a customer confirmation code that was generated by the customer’s
mobile communication device in response to the random code. The customer confirmation code is
then used by the ATM to verify the customer’s identity by analyzing the customer confirmation code
with respect to the random code, and controlling the transaction by providing or preventing access
to a keypad of the ATM based on the analysis of the code data. Considered individually, the ATM
obtaining information from a bank card and the processor comparing data do not provide
significantly more for the same reasons as in claim 1. Similarly, the ATM and the mobile
communication device are recited at a high level of generality and perform programmed functions
that represent conventional and generic operations for these devices, including reading data,
generating random codes, and analyzing data.
However, the combination of the steps (e.g., the ATM’s provision of the random code, the mobile
communication device’s generation of the customer confirmation code in response to the random
code, the ATM’s analysis of the customer confirmation code, and the ATM’s subsequent sending of a
control signal to provide or prevent access to the keypad of the ATM and thus allow or prevent a
transaction based on the analysis of the code data sets) operates in a non‐conventional and non‐
generic way to ensure that the customer’s identity is verified in a secure manner that is more than
the conventional verification process employed by an ATM alone. In combination, these steps do not
represent merely gathering data for comparison or security purposes, but instead set up a sequence
of events that address unique problems associated with bank cards and ATMs (e.g., the use of stolen
or “skimmed” bank cards and/or customer information to perform unauthorized transactions).
Thus, like in BASCOM, the claimed combination of additional elements presents a specific, discrete
implementation of the abstract idea. Further, the combination of obtaining information from the
mobile communication device (instead of the ATM keypad) and using the customer confirmation
code (instead of a PIN) to verify the customer’s identity does not merely select information by content
or source, in contrast to Electric Power, but instead describes a process that differs from the routine
and conventional sequence of events normally conducted by ATM verification, such as entering a PIN,
similar to the unconventional sequence of events in DDR. The additional elements in claim 3 thus
represent significantly more (i.e., provide an inventive concept) because they are a practical
implementation of the abstract idea of fraud prevention that performs identity verification in a non‐
conventional and non‐generic way, even though the steps use a combination of well‐known
components (an ATM and mobile communication device). Claim 3 is eligible (Step 2B: Yes).
While an examiner would not be required to provide an explanation of eligibility, the record would
be enhanced if clarifying remarks were provided to point to the reason for eligibility. In this instance,
clarification could easily be made by simply pointing to the combination of elements used in the non‐
conventional implementation of identity verification in the method of fraud prevention.
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Background
Inventory management is a commercial practice involving the acquisition and monitoring of stocked
goods to maintain stock levels in a business. Particularly when goods are stored in large warehouses,
managing inventory requires monitoring what goods are currently in stock and where those goods
are located in the warehouse in order to fulfill orders in an efficient manner. Some prior methods of
tracking inventory required items of inventory to have an attached tracking device such as a RFID or
GPS transmitter, but these methods were cumbersome to implement since each item needed a
transmitter to be affixed and detached as the item entered and exited the warehouse. In addition,
these methods could not accurately track an item if the transmitter was obscured, improperly affixed,
or detached from the item. Other prior methods used imaging technology to acquire and process
images to track the items of inventory, but these methods did not have much success because they
used the view of a single camera to track an object and attempted to identify items solely based upon
character data (such as identification codes or product names) printed on the item. Due to using the
view of a single camera to track an object, it was difficult to determine an object’s physical three‐
dimensional (3‐D) location. Therefore, these methods required items that were moved to be
reimaged or otherwise tracked through manual scanning or logging. Mistakes in data entry or failure
to scan a moved item resulted in lost or misplaced items. Accordingly, previous attempts to
implement image recognition to track items of inventory have not achieved a high rate of accuracy.
Applicant has invented a system for tracking the presence and location of items of inventory in a
warehouse using an integrated camera system with computer vision technology that overcomes
many of the problems in the existing technologies typically used in the industry. Applicant’s system
overcomes the issues relating to accurately identifying items and tracking missing items by using a
high resolution video camera array with overlapping views in combination with a recognition model
that uses not only the character data of the item but also contour information (i.e. shape) from the
collected images and predictive location data. By using a combination of character and contour
recognition, applicant’s system greatly reduces the possibility of item misidentification and
significantly improves accuracy of inventory over prior techniques that used only character
information. Because the cameras in the array have overlapping views, objects can be tracked across
multiple cameras and the 3‐D location of the objects can be automatically reconstructed. Applicant’s
improvement to computer vision technology to manage inventory within existing warehouse
operations thus results in more accurate inventory tracking while eliminating the need for
procedures such as scanning and logging items.
In practice, the invention uses high resolution video cameras positioned to have overlapping fields
of view in pre‐determined locations throughout the inventory storage space. Such cameras enable
the system to automatically track an item across the entire storage space and estimate its physical
location. An inventory recognition model is also stored in the memory and comprises a mathematical
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Subject Matter Eligibility Examples: Business Methods
representation of each item of inventory handled by the particular warehouse. This model may be a
Gaussian mixture model, neural network, Bayes classifier or other known pattern classifier. The
model is developed using a supervised training algorithm using numerous images of each item at
multiple distances and positions with respect to the camera. During training, characteristics of each
item are extracted from the images including character information such as the item’s name and
identification code and contour information such as the shape of the item and/or the shape of the
packaging for the item. The recognition model may be updated as needed when items are added or
discontinued.
During operation, the video cameras capture an image sequence (e.g., multiple images from one or
more of the cameras) comprising overlapping images of an item, which is stored in the memory in an
inventory record. The system then uses a programmed computer to extract characteristics of an item
including character and contour information from the high resolution images in the image sequence
using a combination of existing text and edge detection algorithms. The programmed computer uses
the characteristics to form feature vectors, and then classify the item by processing the feature
vectors with the inventory recognition model to determine the most likely item in the image. A
positive recognition result indicates the presence of the item in the warehouse. After an item is
recognized, it is tracked in real‐time throughout the warehouse using a tracking algorithm that takes
advantage of the overlapping camera views to confirm the location of the item (thus improving
retrieval time and accuracy). Specifically, the item is tracked in the image sequence of one camera
using a known method, such as Kalman filtering, and once that item enters the field of vision of a
second camera, its position in the first camera’s view is used to quickly locate the item in the second
camera’s view. The item can then be tracked similarly in the image sequence of the second and
subsequent cameras. The computer then reconstructs the 3‐D coordinates of the item based upon
the item’s location in multiple overlapping images and prior knowledge of the location and field of
view of the camera(s) that are tracking the item. Finally, the computer updates the item’s inventory
record with the 3‐D location information.
In this hypothetical scenario, computer vision technology has not been used in the manner disclosed
by this inventor prior to the filing of the application.
Claims
1. A system for managing an inventory record comprising a memory and processor configured
to perform the steps of:
(a) creating an inventory record for an item of inventory comprising acquired images of the
item;
(b) adding classification data relating to the acquired images to the inventory record;
(c) adding location data relating to each acquired image to the inventory record; and
(d) updating the inventory record with a physical location of each item of inventory in the
warehouse to thereby manage the items of inventory.
2. A system for managing an inventory record by tracking the location of items of inventory in
a warehouse:
a high‐resolution video camera array, each video camera positioned at pre‐determined
locations with overlapping views, for acquiring at least one high‐resolution image sequence
of each item of inventory;
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Subject Matter Eligibility Examples: Business Methods
Analysis
Claim 1: Ineligible
The claim recites a system for managing an inventory record comprising a memory and a processor
configured to perform a series of steps. The claimed system is a device or set of devices, which is a
machine and thus a statutory category of invention (Step 1: Yes).
The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim
recites a system that performs the steps of (a)‐(c) storing acquired images and related classification
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Subject Matter Eligibility Examples: Business Methods
and location data, and (d) updating the inventory record with the physical location of each item of
inventory in the warehouse. That is, the claim describes the steps of managing inventory by creating
an inventory record for each item of inventory comprising images of the item, adding classification
data relating to the images to the inventory record, adding location data for each image to the
inventory record, and updating the inventory record with the physical location of each item of
inventory in the warehouse. The data collection, recognition, and storage concept described in the
claim is similar to the data collection and management concepts that were held to be abstract ideas
in Content Extraction, TLI Communications, and Electric Power Group. Although the claim enumerates
the type of information (i.e., the images, classification data, and location data) that is acquired, stored
and analyzed, the Federal Circuit has explained in Electric Power Group and Digitech that the mere
selection and manipulation of particular information by itself does not make an abstract concept any
less abstract. Further, the claim is not made any less abstract by the invocation of a programmed
computer. Unlike Enfish, where the claims were focused on a specific improvement in how the
computer functioned, the claim here merely uses the computer as a tool to perform the abstract
concepts. Therefore, based on the similarity of the concept described in this claim to abstract ideas
identified by the courts, claim 1 is directed to an abstract idea (Step 2A: Yes).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim
recites the additional limitations of a memory and processor to perform the steps of inventory
tracking. A memory for storing data and a processor for processing data are well‐understood,
routine, conventional computer components, which in this claim are recited at a high level of
generality and perform generic computer functions (e.g., storing and processing information).
Generic computer components performing generic computer functions, alone, do not amount to
significantly more than the abstract idea.
Viewing the limitations in combination also fails to amount to significantly more than the abstract
idea. The claimed invention seeks to record, process, and archive digital images simply, fast, and in
such a way that the information may be easily tracked, but these functions reflect ordinary usage
typically performed by a generic computer, as would be recognized by those of ordinary skill in the
field of data processing. For example, as noted in TLI Communications, using a computer to attach
classification data, such as dates and times, to images for purposes of storing those images in an
organized manner does not add significantly more to a judicial exception. The recitation of
conventional processing technology performing well‐understood, routine, conventional functions
such as recognizing and storing data from specific data fields does not reflect an “inventive concept.”
Thus, whether viewed individually or in combination, the additional limitations do not amount to a
claim as a whole that is significantly more than the abstract idea (Step 2B: No). The claim is not patent
eligible.
A rejection of claim 1 should identify the abstract idea by pointing to the language of the claim that
describes inventory management and explaining that inventory management is similar to concepts
that courts have previously found abstract. The rejection should identify the additional limitations
regarding the memory and processor and explain why those limitations comprise only a generic
computer performing well‐understood, routine, conventional generic functions in the particular
technological environment of image processing, for the reasons noted above.
Claim 2: Eligible
The claim recites a system comprising a video camera array, a memory and a processor. The system
is a device or set of devices and therefore is a machine, which is a statutory category of invention
(Step 1: Yes).
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Subject Matter Eligibility Examples: Business Methods
The claim is then analyzed to determine if the claim is directed to a judicial exception. Like claim 1,
claim 2 recites a system that performs the steps of (a)‐(c) acquiring and storing images and related
data about items of inventory, and (e) updating the inventory record with the physical location of
each item of inventory in the warehouse. Claim 2 thus describes using data collection and
management techniques to practice the concept of inventory management, which as explained above
is an abstract idea. Therefore, the claim is directed to an abstract idea (Step 2A: Yes).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim
recites the additional limitations of a high‐resolution video camera array at predetermined positions
with overlapping views, memory and processor to (d) reconstruct the 3‐D coordinates of the item of
inventory from multiple overlapping images obtained from the camera array and prior knowledge of
the location and field of view of the camera(s). Individually, the memory and processor limitations
do not amount to significantly more for the reasons discussed above for claim 1. For example, they
are still well‐understood, routine, conventional devices that are used in this invention for their
conventional functions of processing and storing information. Similarly, high‐resolution video
cameras are widely used and, in this invention, perform their typical function of acquiring image
sequences.
However, the memory and processor in combination with a high‐resolution video camera array with
predetermined overlapping views that reconstructs the 3‐D coordinates of the item of inventory
using overlapping images of the item and prior knowledge of the location and field of view of the
camera(s) provides significantly more than the abstract idea of using data collection techniques to
manage inventory. As explained in the specification, at the time of this invention, using a high‐
resolution video camera array with overlapping views to track items of inventory was not well‐
understood, routine, conventional activity to those in the field of inventory control. In fact, the use
of this camera array provides the ability to track objects throughout the entire storage space rather
than simply the view of a single camera and determine their 3‐D location without any of the manual
steps that were required of previous methods. That is, the video camera array with reconstruction
software provides the technological solution to the technological problem of automatically tracking
objects and determining their physical position using a computer vision system. Like in DDR, the
claimed solution here is necessarily rooted in computer technology to address a problem specifically
arising in the realm of computer vision systems. The claimed limitations are not simply an attempt
to generally link the abstract idea to the technological environment of computer vision systems.
Rather, these are meaningful limitations that confine the claim to a particular useful application.
Accordingly, when viewed as a combination, the additional elements thus yield a claim as a whole
that amounts to significantly more than the abstract idea of inventory management (Step 2B: Yes).
The claim is patent eligible.
If the examiner believes the record would benefit from clarification, remarks could be added to the
Office action or reasons for allowance indicating that the claim recites the abstract idea of inventory
management. Nevertheless, the claim is eligible because analyzing the claim elements in combination
demonstrates the claim is a technology‐based solution to address a problem arising in the realm of
computer vision systems and is not simply limiting the abstract idea to a particular technological
environment.
Claim 3: Eligible
The claim recites a system comprising one or more video cameras, memory and a processor. The
system is a device or set of devices and therefore is a machine, which is a statutory category of
invention (Step 1: Yes).
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Subject Matter Eligibility Examples: Business Methods
The claim is then analyzed to determine if the claim is directed to a judicial exception. Like claim 1,
claim 3 recites a system that performs the steps of (a) & (c) storing acquired images and related
classification and location data, and (e) updating the inventory record with the physical location of
each item of inventory in the warehouse. Claim 3 thus describes using data collection and
management techniques to practice the concept of inventory management, which as explained above
is an abstract idea. Therefore, the claim is directed to an abstract idea (Step 2A: Yes).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,
is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim
recites the additional limitations of a high‐resolution video camera array for acquiring high
resolution image sequences of items of inventory, a memory to store the acquired images, related
data, and the recognition model, and a processor to perform step (b)’s extracting characteristics from
the acquired images, step (c)’s recognizing and tracking the position of the item using the recognition
model and step (d)’s determining a physical location of the item using the position of the item in the
images. Individually, the camera array, memory and processor limitations do not amount to
significantly more for the reasons discussed above for claims 1 and 2. For example, these
components are used in this invention for their well‐understood, routine, conventional functions of
acquiring, processing and storing information.
In combination, however, the limitations do amount to significantly more than the abstract idea of
inventory management. As explained in the specification, the combination of the camera array’s
acquisition of high resolution image sequences, and the processor’s performance of step (b)’s
extracting contour and character information from the images to create feature vectors, step (c)’s
recognizing and tracking items of inventory using the feature vectors and a recognition model, and
step (d)’s determining the physical location of the recognized items using the position of the item in
the image sequence(s) is not well‐understood, routine, conventional activity in this field. This
combination of limitations provides a hardware and software solution that improves upon previous
inventory management techniques by avoiding the cumbersome use of RFID and GPS transmitters
and the inaccuracy issues that plagued previous computer vision solutions. This combination of
features provide meaningful limitations to the practical application of inventory tracking with
computer vision, by improving the system’s ability to identify and track objects across multiple
cameras in a three‐dimensional space. These limitations do not simply limit the abstract idea to the
technological environment of image processing, but are instead meaningful limitations that integrate
the abstract idea into a particular application that uses character and contour information from high
resolution images to recognize items of inventory. When viewed as a combination, the additional
elements thus yield a claim as a whole that amounts to significantly more than the abstract idea of
inventory management (Step 2B: Yes). The claim is patent eligible.
If the examiner believes the record would benefit from clarification, remarks could be added to the
Office action or reasons for allowance indicating that the claim recites the abstract idea of inventory
management. Nevertheless, the claim is eligible because analyzing the claim elements in combination
demonstrates the claim is a particular application rather than well‐understood, routine, conventional
activity or simply limiting the abstract idea to a particular technological environment.
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